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Found 13 results

  1. Celiac.com 06/23/2017 - Dr. Alessio Fasano from the University of Maryland's Celiac Research Center published a paper in Clinical and Developmental Immunology last month. It focused on a new drug developed by Dr. Fasano that has shown promising results in both animal and human trials. But is this the 'magic pill' that will cure celiac disease and gluten sensitivity? Let's take a look. The new drug, formerly called AT1001 but now renamed Larazotide Acetate, is a zonulin inhibitor. For those who have never heard the word 'zonulin', you might think it's a term from a science fiction movie. But zonulin is the protein that causes the 'gates' or openings between the cells making up the lining of the small intestine to open and close. These openings are called tight junctions and when zonulin gets excessive, a leaky gut ensues. Dr. Fasano has made great inroads to prove that a leaky gut is a problem that must be handled with gluten intolerance. The leaky gut perpetuates gluten's negative impact on other parts of the body. It can also initiate autoimmune disease. One key point to keep in mind is that 'leaky gut' occurs because molecules can pass between cells when they shouldn't. In addition, molecules can pass through cells which they also shouldn't. Unfortunately this new drug only impacts the former, not the latter. So, the drug Larazotide Acetate is a zonulin inhibitor. Now that we've reviewed what zonulin does as regards opening the gates, the purpose of inhibiting its action should make sense. How well does it work? In the recent human trials that were double-blind, randomized placebo-controlled (the best type of study, but I would expect no less from the stellar Dr. Fasano), a gluten exposure created a 70% increase in intestinal permeability (leaky gut) in 57% of the placebo group but only 28.6% of the patients receiving the drug (4 out of 14 patients) experienced such increased permeability. Further, gastrointestinal symptoms were significantly more frequent among patients of the placebo group as compared to the group that received the Larazotide. A pro-inflammatory substance known as interferon gamma was also evaluated. This is manufactured by the body when a specific foreign/toxic agent is recognized by the body's immune system. As expected, levels of interferon gamma increased in 4 out of 7 of the placebo patients (57%) but only 4 out of 14 larazotide patients (28.6%) saw any increase. The good news is that this drug seems well tolerated and it does reduce the leaky gut response that gluten ingestion normally creates. Further, it also reduces the percentage, by about half, of the production of interferon gamma. These are all excellent results. But, and it's unfortunately a very big 'but', we have a very long way to go before such a drug would be useful for your typical celiac or gluten sensitive patient. Will Dr. Fasano and his team be able to tweak this drug such that it functions at a higher level of efficacy? I certainly hope so, but let's analyze exactly what this drug does in its present state: The drug still resulted in almost 30% of the patients experiencing a 70% increase in permeability (leaky gut) – Not good. A highly pro-inflammatory (this means that it creates degenerative disease) substance known as interferon gamma was also produced in nearly 30% of the drug-consuming patients tested – Not good. Leakiness, or the passage of negative substances through cells is not affected by this drug – Not good. Of course on the plus side, over 70% of those tested DID have a very good result with apparently no untoward side effects – Very good. At what point is the efficacy high enough that you'd be willing to subject yourself to a possible reaction? Do realize that any gluten ingested increases your chance of disease, chief amongst them cancer and autoimmune disease. Is there a level of function of the drug that you would chance taking it? Is it 90%, 99%? Does any drug ever get that good? Well, as a big fan of Dr. Fasano's, I would say that if anyone can do it, he and his team can. But at the same time, I cannot help but think of all the other drugs I have encountered. As 'wonderful' as they sometimes seem initially, they almost always fall from grace when some horrible side effect is realized. Would I guinea pig my own health that I've fought so hard to regain? Would I recommend taking such a chance to my children just so that they could consume some white flour product? I don't think so. How about you? What do you think? If the drug were available right now at its efficacy of 71%, would you take it and hope you weren't in the 29% for whom it didn't work? I'd love to hear your thoughts. If you are wondering if you're gluten intolerant or know that you are but still aren't enjoying good health, consider calling us for a free health analysis: 408-733-0400. We are here to help! Our destination clinic sees patients from across the country and internationally so you do not need to live locally to receive assistance. To your good health! Reference: Alessio Fasano, Clinical and Developmental Immunology, Published online 2012 October 10. "Novel Therapeutic/Integrative Approaches for Celiac Disease and Dermatitis Herpetiformis."
  2. Celiac.com 09/25/2017 - There are currently several efforts underway to develop successful commercial enzyme treatments for celiac disease. Efforts include looking at the digestive enzymes in plants, such as the papaya and star fruits, including such predatory plants, such as the pitcher plant. One focus has been on developing enzymes that can break down gluten before it can trigger an immune reaction. This could prove helpful to many people with celiac disease. One such enzyme under development is Latiglutenase, formerly known as ALV003. Latiglutenase is a new name for an enzyme therapy designed to be taken with meals. The idea is that a person with celiac disease would take an enzyme tablet with a meal. If the meal had mild gluten contamination, the enzyme’s two recombinant proteins would break gluten into fragments that are not toxic to the immune system, thereby preventing exposure, and symptoms. But the stomach is a notoriously difficult environment to work in, so what seems like a simple idea quite a challenge from a science and biology perspective. Seeking to explore the ability of Latiglutinase to improve symptoms, a team of researchers recently set out to test latiglutenase on celiac patients who are seropositive despite following a gluten-free diet. The research team included Jack A. Syage, Joseph A. Murray, Peter H. R. Green and Chaitan Khosla. They are variously affiliated with the Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester USA, the Celiac Disease Center at Columbia University, New York, USA, the Departments of Chemical Engineering and Chemistry, Stanford University, USA, and with ImmunogenX, Newport Beach, USA. "Though the ALV003-1221 trial was inconclusive regarding histologic improvement from latiglutenase, the evidence for symptom benefit, which is more quickly achieved, is quite convincing and clinically relevant," Joseph Murray, MD, of the Mayo Clinic in Rochester, Minn., said in a press release. In these trials, patients with celiac disease who were seropositive despite following a gluten-free diet saw major improvement in symptoms when taking latiglutenase with meals, according to a post hoc analysis of the CeliAction study. The team was really hoping to see histological improvement, but they feel satisfied that this trial shows, says Dr. Murray, that a "therapy to help patients struggling with symptoms due to celiac disease is now within reach." Stay tuned for more on efforts to develop effective enzyme treatments for celiac disease. Read more: Dig Dis Sci. 2017 Doi:10.1007/s10620-017-4687-7.
  3. Celiac.com 06/26/2017 - Designed to reduce or eliminate symptoms of gluten contamination in gluten-sensitive individuals, the product known as AN-PEP, marketed in the U.S. as Tolerase G, is a prolyl endoprotease enzyme, derived from Aspergillus niger, that has shown promise in breaking down gluten proteins. The latest news comes in the form of a small study that shows the enzyme to be effective in the stomach itself, where harshly acidic conditions render many enzymes ineffective. Speaking to an audience at Digestive Disease Week (DDW) 2017, lead investigator Julia König, PhD, of Sweden's Örebro University, said that the enzyme was special, because…[t]here are a lot of enzymes on the market, but this functions in the stomach where the pH is acidic. Often enzymes don't work in this environment." König was also quick to caution that "you cannot use this enzyme to treat or prevent celiac disease." The enzyme is not intended to replace a gluten-free diet for celiac patients. The enzyme is designed to provide some protection against cross-contamination for people with gluten-sensitivity by breaking down modest amounts of gluten to reduce or prevent adverse immune reaction. A previous study showed that AN-PEP breaks down gluten after an intra-gastrically infused liquid meal in healthy volunteers (Aliment Pharmacol Ther. 2015;42:273-285). In the latest randomized placebo-controlled crossover study, Dr König and her colleagues assessed the ability of AN-PEP to degrade gluten after a normal meal in people with gluten sensitivity. The research team looked at 18 people with self-reported gluten sensitivity, and with no confirmation of celiac disease. On three separate visits, investigators collected gastric and duodenal aspirates with a multilumen nasoduodenal-feeding catheter. Participants then consumed a porridge containing gluten, approximately 0.5 g, in the form of two crumbled wheat cookies. They also consumed a tablet containing AN-PEP at either 160,000 PPi or 80,000 PPi), or placebo. Investigators collected stomach and duodenal aspirates over the following 3 hours. In both the high- and low-dose AN-PEP groups, gluten concentrations in the stomach and in the duodenum were substantially lower than in the placebo group. This study shows that AN-PEP does break down gluten in the stomach, where many enzymes fail. If successfully tested and commercially released, AN-PEP could help people with gluten sensitivity, including those with celiac disease, to reduce or eliminate symptoms associated with casual gluten contamination. Source: Medscape
  4. Celiac.com 10/14/2014 - A new drug designed to prevent gluten uptake in the gut is showing some promise for the treatment of celiac disease. The drug, larazotide acetate, significantly reduced symptoms in a large double-blind, placebo-controlled trial. The drug prevents gluten uptake by closing tight junctions in the gastrointestinal (GI) tract. The drug is intended to supplement, rather than replace, the gluten-free diet that makes up the standard celiac disease treatment. Specifically, the drug is designed to help patients who continue to experience symptoms despite efforts to avoid gluten, and will not allow celiac patients to eat gluten with impunity. Some experts are cautioning celiac disease patients against high expectations. Joseph A. Murray, MD, of the Division of Gastroenterology and Hepatology at Mayo Clinic, in Rochester, Minnesota, said that, even if the drug is approved, it would not be a cure for celiac disease, but just another way to control symptoms for those already on a gluten-free diet. Daniel Leffler, MD, director of research at the Celiac Center of Beth Israel Deaconess Medical Center, in Boston, called the news “exciting.” Dr. Leffler predicted that, if approved, the drug would be a useful addition to standard celiac disease treatment. Source: Gastroenterology and Endoscopy News. SEPTEMBER 2014 | VOLUME: 65:9
  5. Celiac.com 11/30/2011 - Researchers have been talking about it for some time, raising the hopes of the celiac community: a drug to help relieve us from the harmful effects of gluten exposure. Celiac patients are closer than ever to having such a drug on the market, as Alvine Pharmaceuticals has announced that their drug ALV003 has shown promise in a clinical trial by reducing gluten-triggered harm in people with celiac disease. Celiac disease is an autoimmune reaction triggered by exposure to gluten, a protein found in wheat, barley, and rye, that causes the immune system to attack the small intestine, interfering with the absorption of nutrients and leading to malnutrition and a variety of other symptoms. The disease currently has only one treatment, which is non-drug: the gluten-free diet. By eliminating gluten completely from the diet, most celiac patients can heal their small intestine. There is currently no other drug on the market that can help relieve the symptoms of celiac disease or the intestinal damage it can cause. Now Alvine Pharmaceuticals, which is focused on developing biopharmaceuticals for autoimmune inflammatory diseases such as celiac disease, has reported favorable results for a trial with their drug ALV003, which was developed to lessen mucosal injury in the intestine caused by gluten exposure in well-controlled celiac patients. A control group study was conducted that collected data from 34 celiac patients. After both the active drug group and placebo group ingested two grams of gluten on a daily basis for six weeks, "The group with the placebo reported higher incidence of 'non-serious adverse events' (code for GI symptoms)," Triumph Dining reported. "They also had significantly more mucosal injury in their small intestines, as measured by biopsy data." ALV003 works by breaking down the gluten molecule into nontoxic parts. (Alvine Pharmaceuticals explains more specifically how the drug works on their website, AlvinePharma.com.) The drug is intended to help alleviate the gastrointestinal and other symptoms associated with cross-contamination, incorrect or misleading "gluten-free" labeling, and exposure to gluten caused by carelessness or imprudence. Even when celiac patients take care to maintain a strict gluten-free, it's difficult to stay completely away from gluten. That's why, according to coordinating investigator of the latest ALV003, Markku Maeki, M.D., chair and professor of pediatrics at the University of Tampere and Tampere University Hospital in Finland, "New non-dietary treatment options that can either eliminate, or meaningfully reduce the gluten present in an attempted gluten-free diet are needed." Currently celiacs have no drug options to help alleviate their symptoms. "These results are groundbreaking," said Professor Maeki, "as they demonstrate for the first time, in a controlled clinical trial, that a drug has the potential to diminish gluten-induced injury in celiac disease patients." According to Triumph Dining, "After Phase 3 trials, so long as results remain promising, ALV003 will enter Phase 2b trials soon; after that come Phase 3 trials and (hopefully) submission to the FDA for approval." The release of ALV003, should results remain favorable, will no doubt bring relief to many members of the celiac community.
  6. Celiac.com 10/14/2013 - A team of researchers recently set out to assesses the safety and efficacy of Aspergillus niger prolyl endoprotease (AN–PEP) to mitigate the effects of gluten in celiac patients. For their study, the researchers included celiac patients with positive serology and subtotal or total villous atrophy on duodenal biopsies, who follow a strict gluten-free diet (GFD) resulting in normalised antibodies and mucosal healing classified as Marsh 0 or I were included. Prior to this randomized double-blind placebo-controlled pilot study, the team measured complaints, quality-of-life, serum antibodies, immunophenotyping of T-cells and duodenal mucosa immunohistology. They then had patients consume approximately 7 grams of gluten per day as toast, along with AN-PEP for a two week safety phase. The team put subjects through a two week washout phase where they followed their usual gluten-free diets. The team then randomly assigned 14 patients to receive gluten, with either AN-PEP or placebo, for a two week efficacy phase. They also collected patient questionnaires on serum and quality of life during and after the safety, washout and efficacy phase. They conducted duodenal biopsies after both the safety phase and the efficacy phase. Change in histological evaluation according to the modified Marsh classification served as the primary endpoint. In all, 16 adults participated in the study. No serious adverse events occurred during the trial and no patients withdrew during the trial. The average score for the gastrointestinal subcategory of the celiac disease quality (CDQ) was relatively high throughout the study, indicating that AN-PEP was well tolerated. In the efficacy phase, the team saw no significant deterioration in the CDQ scores of patients consuming gluten with placebo or gluten with AN-PEP, nor did they observe any other differences between the groups. During the efficacy phase, neither the placebo nor the AN-PEP group showed significant antibody titers. IgA-EM concentrations remained negative in both groups. The team excluded two patients from entering the efficacy phase because their mucosa showed an increase of two Marsh steps after the safety phase, yet with undetectable serum antibodies. A total of 14 patients were considered histologically stable on gluten with AN-PEP. Also, after the efficacy phase, the team saw no significant deterioration in immunohistological and flow cytometric evaluation in the group consuming placebo compared to the group receiving AN-PEP. Furthermore, in four out of seven patients on placebo, IgA-tTG deposit staining increased after two weeks of gluten intake compared to baseline. In the seven patients receiving AN-PEP, one patient showed increased and one showed decreased IgA-tTG deposits. AN–PEP appears to be well tolerated. However, the primary endpoint was not met due to lack of clinical deterioration upon placebo, impeding an effect of AN–PEP. The research team included Greetje J Tack, Jolanda MW van de Water, Chris J Mulder of the Department of Gastroenterology and Hepatology, VU University Medical Centre in Amsterdam, The Netherlands; Engelina MC Kooy-Winkelaar, Jeroen van Bergen, and Frits Koning of the Department of Immunohematology and Blood Transfusion, Leiden University Medical Centre in Leiden, The Netherlands; Petra Bonnet, B Mary E von Blomberg, and Marco WJ Schreurs from the Department of Pathology, VU University Medical Centre, in Amsterdam, The Netherlands; Anita CE Vreugdenhil, with Department of Paediatrics, University Hospital Maastricht in Maastricht, The Netherlands; and Ilma Korponay-Szabo, with the Department of Paediatrics, University of Debrecen in Hungary, and the Paediatric Research Centre, University of Tampere, in Tampere, Finland. Source: World Journal of Gastroenterology, 10/03/2013
  7. Celiac.com 11/14/2011 - Alvine Pharmaceuticals claims that Phase 2a clinical trial of ALV003 demonstrates the drug's ability to mitigate gluten-triggered intestinal mucosal damage in serologically negative celiac disease patients who followed a gluten-free diet for one or more years. The company presented findings from the study at the 19th United European Gastroenterology Week (UEGW) in Stockholm. Alvine will present their data in an abstract, titled "ALV003, a Novel Glutenase, Attenuates Gluten-Induced Small Intestinal Mucosal Injury in Celiac Disease Patients: A Randomized Controlled Phase 2A Clinical Trial," The results are important because "up to 60 percent of adult celiac disease patients continue to experience symptoms and up to 80 percent continue to have persistent intestinal inflammation despite adhering to a strict gluten-free diet," says Markku Maeki, M.D., chair and professor of pediatrics at the University of Tampere and Tampere University Hospital in Finland, and coordinating investigator of the ALV003 Phase 2a trial. Finding a treatment that can help eliminate gut damage in celiacs who are following a gluten-free diet is an important step in improving long-term treatment of celiac disease. Doctor Peter Green, M.D., agrees. Dr. Green is director of The Celiac Disease Center and professor of clinical medicine at Columbia University College of Physicians and Surgeons. He says that a "gluten-free diet does not completely prevent exposure to gluten and does not affect the underlying cause of disease." This can potentially leave patients "vulnerable to gastrointestinal symptoms and serious long-term medical consequences," he says. Simply put, Dr. Green says, "there are currently no approved therapies for celiac disease. For the trial, 41 adults with clinically proven celiac disease, and who followed on a gluten-free diet for one or more years, received ALV003 or a placebo each day for six weeks. Test subjects also received 2g of gluten in the form of bread crumbs. Each subject received small bowel biopsy at the start of the trial, and again after six weeks of daily gluten challenge. Researchers obtained biopsy results from 34 patients. Results showed significantly less small intestinal mucosal injury in patients treated with ALV003 than in placebo-treated patients after six weeks (p=0.013). Placebo-treated patients suffered more adverse events, most commonly including abdominal distention, flatulence, eructation, abdominal pain and diarrhea. "Based on the results of this rigorously conducted trial, we believe that clinical proof-of-principle has been achieved. We are currently preparing for a Phase 2b trial of ALV003 in celiac disease patients targeted to begin in 2012," said Daniel Adelman, chief medical officer at Alvine Pharmaceuticals. Source: PRESS RELEASE Oct. 11, 2011, 8:00 a.m. EDT The full abstract (#OP050B) can found on the UEGW website: www.uegw11.uegf.org.
  8. Celiac.com 05/21/2009 - To better diagnose celiac disease, assess intestinal damage, and monitor treatment over the long-term, doctors are looking to develop a whole new set of non-invasive evaluation tools. One of the tools currently of interest are fatty acid binding proteins (FABPs), these are small cytosolic proteins found in enterocytes (tall columnar cells and responsible for the final digestion and absorption of nutrients, electrolytes and water). FABPs are reliable indicators of intestinal mucosal damage, and are potentially useful for non-invasive assessment of intestinal damage in celiac patients. A team of researchers in the Institute of Nutrition and Toxicology Research at Maastricht University, as well as the departments of Surgery, Pediatrics and Internal Medicine at University Hospital Maastricht, recently set out to assess the potential use of FABPs in non-invasive assessment of intestinal damage in celiac disease. The study team was made up of J. P. Derikx, A. C. Vreugdenhil, A. M. Van den Neucker, J.Grootjans J, A. A. van Bijnen, J.G. Damoiseaux, L. W. van Heurn, E. Heineman, and W. A. Buurman. They began by examining the distribution and microscopic localization of FABPs in healthy human intestinal tissue. They then checked circulating levels of intestinal (I)-FABP and liver (L)-FABP in 26 healthy control subjects, and in 13 patients with biopsy-proven celiac disease, both before and after initiating a gluten-free diet. Ten celiac subjects underwent reevaluation within a year beginning a gluten-free diet. They found that I-FABP and L-FABP are common in the small intestine, particularly in the jejunum. FABPs also show up in cells on the upper part of the villi, the part that is first to be damaged in celiac disease. They also found that people with untreated, biopsy-proven celiac disease have substantially higher circulating levels of FABPs as compared with healthy control subjects (I-FABP: 784.7 pg/mL vs. 172.7 pg/mL, P<0.001; L-FABP: 48.4 ng/mL vs. 10.4 ng/mL, P<0.001). These levels return to normal when patients adopt a gluten-free diet. According to the team, the monitoring of FABP circulating levels shows strong promise as a non-invasive means of diagnosing and assessing intestinal damage in celiac disease, as well as in long-term non-invasive monitoring of treatment and gluten-free diet compliance. Journal of Clinical Gastroenterology. 2009 Apr 6.
  9. Celiac.com 11/03/2008 - Blood testing for radioimmunoassay (RIA) tissue transglutaminase auto-antibodies (tTG-Abs) has proven to be a sensitive test for celiac disease follow-up. Recent studies have shown that RIA can accurately detect tTG-Abs in human saliva. However, not much is known about reliability of this method for monitoring the progress of celiac disease over time in patients who are attempting to follow a gluten-free diet. A team of researchers recently set out to assess salivary RIA tTG-Abs in celiac children on gluten-free diet. The research team included doctors M. Bonamico, R. Nenna, R.P.L. Luparia, C. Perricone, M. Montuori, F. Lucantoni, A. Castronovo, S. Mura; A. Turchetti, P. Strappini, and C. Tiberti. The team evaluated blood and saliva samples taken from 109 children at the time of their diagnosis for celiac disease. The first group included 71 females, with an average age of 9.4 years. A second group included 58 people who were following a gluten-free diet. The second group was broken into two subgroups: group 2a with 36 patients assessed at 3-6 months; and group 2b with 34 patients at 9 months or more (group 2b). The research team also included two control groups matched for age and sex. Group 3 included 89 gastroenterological patients, while group 4 included 49 healthy subjects. The team used RIA to detect tTG-Abs in saliva and blood, and compared the results against two other established tests: serum tTG-Abs ELISA and IgA anti-endomysium antibodies (EMA). The team detected salivary RIA tTG-Abs in 94.5% of patients from group 1, 66.7% of celiac patients from group 2a, and 50.0% from 2b. They detected blood RIA tTG-Abs in 98.2% of patients from group 1, 72.2% of celiac patients from group 2a, and 50.0% from 2b. The longer patients were on a gluten-free diet, the more the tTG-Abs decreased. The research team also found a correlation between saliva and serum levels (r = 0.75, P = 0.0001). A celiac disease follow-up showed comparable salivary and serum RIA sensitivities, and higher levels for EMA and ELISA methods. The research team concluded that it is possible to measure salivary tTG-Abs with a high level of accuracy; both at initial diagnosis for celiac disease, and also while patients are following a gluten-free diet. This discovery means that doctors treating people with celiac disease might soon be able to use a simple saliva test to monitor the progress of their patients’ gluten-free diets. Such a development might take remove much of the guesswork for celiacs who are trying to follow a gluten-free diet, and would be particularly useful for patients who might be asymptomatic, or who are at risk for celiac-associated conditions. Aliment Pharmacol Ther. 2008; 28(3): 364-370.
  10. Celiac.com 09/10/2007 - Nuvelo has announced Phase 1 trials of NU206 (R-spondin1) gastrointestinal growth factor product on cancer patients who are receiving radiation or chemotherapy treatment for cancer. NU206 is a recombinant, secreted protein that early animal studies show to act as a highly specific stimulator of the gastrointestinal (GI) epithelial cells. Preclinical studies suggest NU206 promotes growth and regeneration of gastrointestinal tissues in animal models of radiation and chemotherapy treatment for cancer, as well as in animal models of inflammatory bowel disease and short bowel syndrome. They expect to follow shortly thereafter with trials on patients with IBD. Mice deficient in IL-10 with drug-inducted colitis serve as research models for human IBD. Studies on such mice show that R-spondin1 substantially prevents mucosal damage and restored mucosal integrity. The implications for repairing and preventing mucosal damage in celiac disease are obvious. In addition to restoring other normal mucosal functions, rapid mucosal repair in celiacs through the use of NU206 therapy would provide relief from the problems caused by increased intestinal permeability. Gastroenterology. 2007 April; 132(4) pgs 1331-1343 health writer who lives in San Francisco and is a frequent author of articles for Celiac.com.
  11. Celiac.com 05/27/2008 - People with celiac disease know all too well that the only effective treatment at present is faithfully following a gluten-free diet. There’s been a lot of talk about various therapies and enzyme treatments that would allow people with celiac disease to return to a normal diet. Talk to anyone who suffers from celiac disease and they’ll likely have a personal horror story about a time when they had an unhappy episode of cross-contamination. So, the idea of a drug that would prevent such symptoms is appealing, and the goal, desirable. The chief cause of recurring symptoms in celiac disease is accidental gluten exposure, usually through cross-contamination. Cross-contamination doesn’t always mean food. Gluten is a common ingredient in many medicines and vitamins, and exposure in celiacs can cause diarrhea, weight loss, abdominal pain, anemia and oral ulcerations in the short-term, and myriad other problems in the long-run. The drug AT-1001 is a good example of how the realities are playing out on the front-lines of science. AT-1001 is an enzyme therapy that has promised some degree of protection from gluten exposure in people with celiac disease. A team of researches recently set out to assess the effectiveness of AT-1001 in preventing gluten from crossing the gut barrier by reversing the defective barrier mechanism. This required evaluating intestinal permeability between those exposed to gluten after taking AT-1001, those exposed without AT-1001, and control groups. The of intestinal function is done by gauging the absorption rates of various sugars. Early testing of AT-1001 showed some progress and a significant rate of protection of celiac patients exposed to wheat proteins. The research team looked at 86 subjects with celiac disease. The patients were divided into three groups. The first group was given placebo AT-1011 and challenged with gluten, the second group was given either active or placebo AT-1001, while the third group was given gluten and active AT-1001. After the first week, all subjects showed improvement, possibly due to closer adherence to a gluten-free diet. At three weeks, those given AT-1001 showed substantial improvement over the group given gluten and placebo AT-1001, including reduced intestinal permeability and fewer symptoms of gluten toxicity. The problem is that while AT-1001 shows a degree of promise, the results are so far underwhelming. The research team noted that the degree of improvement did not match the primary study. The results are, however, strong enough to encourage researchers to conduct a larger trial of AT-1001, which is currently underway. It’s important to remember that celiac disease is an immune disorder and no immune disorder has ever been fully cured. So, the idea of people with celiac disease being able to take a pill and head out for a night of pizza and beer without the standard celiac-related reactions is far-fetched at best. At best, such drugs would likely help to prevent cross-contamination, rather than conveying immunity to gluten proteins. Until then, stay tuned…best of luck with the gluten-free diet! Presented by Dr. Leffler at the 2009 Digestive Disease Week on Tuesday, May 20 at 10:45 a.m. Pacific Time in room 10, San Diego Convention Center.
  12. Celiac.com 06/26/2007 - The results of a study recently published in the online science journal Nature Genetics have revealed a previously unknown genetic risk factor for celiac disease. An international team of researchers set out to study the genetic causes of intestinal inflammatory disorders. When the study began, it was well known that individuals with celiac disease have specific tissue types that identify wheat proteins. Why healthy individuals with the same tissue type failed to develop celiac symptoms or celiac disease remained unknown, and was a key question the team set out to answer. The team was led David van Heel, Professor of Gastrointestinal Genetics at Queen Mary, University of London. The Human Genome Project and the Hap Map Project played key support roles in the study. The results show that a protective DNA sequence in a specific gene segment, generally found in healthy individuals are missing in people with celiac disease. The research team evaluated genome data of 778 individuals with celiac disease and 1,422 controls non-celiacs within the British, Irish and Dutch populations. Key DNA Sequence Missing in Celiacs Researchers discovered that, compared to people with celiac disease, healthy people more commonly have a DNA sequence in the interleukin-2 and interleukin-21 gene region that protects against celiac disease. Interleukin-2 and interleukin-21 are cytokine proteins that are secreted by white blood cells, and which control inflammation. In people with celiac disease, the protective DNA sequence most likely leads to lesser amounts of these cytokines being produced, which weakens the defense against intestinal inflammation. Breakthrough in Better Understanding Risk Factors for Development of Celiac Disease About 1 in 133 people develop the disease, but, so far, predicting those at risk to develop the disease has been haphazard at best. Present methods of genetic testing can only narrow down the search to about 30% of the general population. These results give doctors a means to discover what further genetic risk factors leave people vulnerable to developing celiac disease. Queen Mary, University of London Press Release - Public release date: 10-Jun-2007 health writer who lives in San Francisco and is a frequent author of articles for Celiac.com.
  13. Celiac.com 10/30/2007 - A recent study published in the August issue of American Journal of Gastroenterology suggest that villous atrophy in suspected cases of celiac disease can be reliably detected by video capsule enteroscopy (VCE). Reliable diagnosis presently demands the identification of tell-tale lesions in the mucosa of the small bowel. Accomplishing such identification requires an endoscopy of the upper gastrointestinal tract, and multiple duodenal biopsies. A team of Italian researchers evaluated the effectiveness of Video Capsule Enteroscopy against the standard endoscopy of the upper GI with biopsies of the second portion of the duodenum in patients suspected of having celiac disease. The research team included Emanuele Rondonotti, M.D.; Cristiano Spada, M.D.; David Cave, M.D.; Marco Pennazio, M.D.; Maria E. Riccioni, M.D.; Italo De Vitis, M.D.; David Schneider, M.D.; Tatiana Sprujevnik, M.D.; Federica Villa, M.D.; Jennifer Langelier, M.D.; Arrigo Arrigoni, M.D.; Guido Costamagna, M.D.; Roberto de Franchis, M.D. The research team tested a total of 43 patients. In 41 patients, VCE reached the ileocecal valve during the reading time. 32 patients were found to exhibit diagnostic histology. Of those, 28 were diagnosed with celiac disease using capsule enteroscopy, for a total sensitivity of 87.5%. Overall, for diagnosing celiac disease, VCE was shown to be 90.9% specific, 96.5% predictive, 71.4% negative predictive, with positive and negative likelihood ratios of 9.6% and 0.14% respectively. Four patients showed normal VCE findings, but were still diagnosed with celiac disease. Of these patients, three had Marsh grade III lesions, and one had Marsh grade I lesions. The ability of VCE to offer high-quality images of small bowel mucosa including high-resolution of the individual villi led the team to conclude the VCE may offer an effective alternative to duodenal biopsy among some patients. As VCE is also far less invasive than the endoscopy/biopsy approach, it may also generate greater patient acceptance. Also, unlike conventional endoscopy/biopsy, VCE offers exploration of the entire small intestine, and may lead to the discovery of damaged villi beyond those areas accessible via endoscopy. Because of the small number of the test subjects, the results, though encouraging, invite a larger and more comprehensive study before VCE becomes an acceptable alternative to conventional endoscopy/biopsy method for diagnosing celiac disease. American Journal of Gastroenterology 2007; 102(8): 1624-1631
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