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Celiac.com 02/28/2024 - We get a lot of questions about what celiac disease trials and studies are going on, but there are so many, it can be hard to keep track. One easy source is the Mayo Clinic, which is at the forefront of a number of research trials, and studies to better understand, and treat celiac disease. Currently, there are more than a dozen exciting clinical trials underway, each focusing on different aspects of the celiac disease. One study aims to assess the effect of gluten on gut barrier function by using a novel gut permeability test developed by Mayo Clinic researchers. Another trial is evaluating the safety and tolerability of a potential new treatment, KAN-101, for celiac disease patients. Additionally, researchers are investigating the effectiveness and safety of numerous compounds for relieving symptoms in adult celiac disease patients. These trials represent important steps forward in advancing our understanding of celiac disease and developing new therapies to improve the lives of those affected by this condition. Celiac disease trials and studies currently underway at the Mayo Clinic facilities include: Gut Permeability Assessment in Celiac and Gluten Sensitive Children Rochester, MN This study will assess the effect of gluten on gut barrier function. Investigators at the Mayo Clinic have developed a new gut permeability test using rhamnose (sugar & water solution), and are hoping to prove its effectiveness in a clinical setting. A Study to Assess the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Celiac Disease Patients Rochester, MN The purpose of this study is to assess the safety and tolerable of single and multiple doses of KAN-101 in patients with Celiac disease. A Study to Evaluate the Effectiveness and Safety of Larazotide Acetate for the Relief of celiac disease Symptoms Rochester, MN The purpose of this study is to assess the effectiveness and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients. Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients Rochester, MN The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of DONQ52 in celiac disease patients and to evaluate the safety and tolerability of DONQ52 in celiac disease patients in the presence of gluten after multiple doses of DONQ52. Furthermore, to characterize the DONQ52 PK profile following single and multiple subcutaneous (SC) dose(s) in celiac disease patients and to investigate the immunogenicity of DONQ52. A Study of the Response to and Changes in Intestinal Permeability 4 hours after a Gluten Challenge in Subjects with Celiac Disease and Non Celiac Gluten Sensitivity Rochester, MN The purpose of this study is to identify mediators—innate immune system and intestinal permeability—of acute onset gastrointestinal symptoms after gluten ingestion in subjects with celiac disease and non-celiac gluten sensitivity. Gut Permeability in Environmental Enteropathy Rochester, MN The goal of this project, to develop a simple and sensitive test of small bowel permeability, will improve the scientific and public health understanding of environmental enteropathy and guide development of preventative and treatment modalities such as clean water and sanitation. Mucosal Interactions in Celiac Disease Rochester, MN To obtain biopsies and blood from subjects not previously known to have celiac disease who are undergoing duodenal biopsies for clinical indications. The subjects will have no prior diagnosis of celiac disease and are eating a gluten-containing diet. The biopsies will be treated “in vitro” with enzymatic digests of gluten derived from bread made from different species of wheat, the auto-antigen tTg, cytokines, or other proteins. A Study to Evaluate the Safety, Effectiveness, and Tolerability of Latiglutenase to Treat Patients with Well-Controlled Celiac Disease Rochester, MN The purpose of this study is to demonstrate a positive correlation of histologic protection (biological signature) and symptom protection (clinical outcome) for latiglutenase treatment versus placebo in Celiac Disease (celiac disease) patients undergoing a deliberate gluten challenge. A Study of the Safety, Pharmacodynamics, Effectiveness, and PK of TIMP-GLIA in Subjects with Celiac Disease Rochester, MN The purpose of this study is to evaluate participants for immune responses and histological changes in the small bowel following 2 doses of TIMP-GLIA or placebo and a 14-day oral gluten challenge. Dose-Ranging Study of the Efficacy and Safety of TAK-101 for Prevention of Gluten-Specific T Cell Activation in Participants With Celiac Disease on a Gluten-Free Diet Rochester, MN The purpose of this study is to compare the number of baseline interferon-gamma (IFN-γ) spot forming units (SFUs) to the number of IFN-γ SFUs after a 6-day oral gluten challenge among HLA DQ2–positive subjects treated with TAK-101 versus placebo. A Study of Simvastatin Metabolism as a Test for Celiac Disease Activity Rochester, MN The purpose of the study is to assess the connection between simvastatin metabolism by an enzyme that varies based on the state of the small intestine in treated celiac disease. Antibody Treatment for Advanced Celiac Disease Rochester, MN Celiac disease is a condition where the immune system attacks the cells of the small intestine. The intestine becomes inflamed and cannot digest food properly. The disease most often causes a reaction to foods that contain gluten. Most people can treat celiac disease with a gluten-free diet. However, some people have digestion problems even on a gluten-free diet. Researchers want to try a new antibody therapy for celiac disease. The treatment may block the immune reaction that causes the disease. They will test this antibody in people who have celiac disease that has not responded to a gluten-free diet. Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic Celiac Disease Patients Rochester, MN This is a phase 2b, multi-center, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a gluten free diet (GFD) for at least one year prior to screening. A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet Rochester, MN; Scottsdale/Phoenix, AZ The purpose of this study is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (celiac disease) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls. A Study of the Safety, Effectiveness and Tolerability of Nexvax-2 in Patients with Celiac Disease (celiac disease) Rochester, MN The purpose of this study is to evaluate the human leukocyte antigen (HLA)-DQ 2.5+ in adults with celiac disease (celiac disease). Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients. Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim Jacksonville, FL; Rochester, MN The purpose of this study is to see if advanced endoscopic imaging may be helpful to accurately distinguish pathological tissue from normal tissue and guide therapy of endoscopically identified pathology. Functional Gastrointestinal Disease, Celiac Disease, and Non-celiac Gluten Sensitivity in an Olmsted County Cohort Rochester, MN The aim of this study is to the number of individuals following a gluten-free diet and possible reasons including symptoms of non-celiac gluten sensitivity and functional gastrointestinal diseases (FGIDs). lso assess Diagnoses and lab values associated with celiac disease, NCGS, and FGIDs will also be assessed, as well as past GI survey data and medical record data available through the Rochester Epidemiology Project. Stay tuned for updates on the progress of these and other related studies! Read more at Mayo.edu

Celiac.com 12/25/2019 - Kevon Looney, the 6'9" 23-year-old forward for the NBA's Golden State Warriors, has announced a change to a meat-free, gluten-free diet, aimed at improving a neuropathic condition, which contributed to a hamstring issue that has plagued him since training camp earlier this season. Looney is no stranger to dietary changes. Prior to the 2017-2018 season, he lost 30 pounds with the help of a personal trainer, some training adjustments, and a switch to a modified Paleo diet. The latest dietary change came after Looney visited the Mayo Clinic in Rochester, Minn., last month, presumably to follow-up on the neuropathic issues that affect his hips. Looney's plan of attack included giving up meat and gluten, as meat-free and gluten-free diets have been shown to improve a number of neuropathy cases. Now a gluten-free and pescatarian, Looney's father, Kevin, serves as his personal chef. Meals now include things like blackened catfish, baked salmon, and vegetables, along with potatoes. The Warriors have struggled so far this season, and are doubtless looking for Looney's diet to boost his health, and hopefully their chances for turning around what has thus far been a decidedly losing season. Do you or a loved one suffer from neuropathy? Have you seen any improvement on a gluten-free diet? Share your experience in our comments below. Read more at NBCSports.com

Celiac.com 08/18/2020 - In the last decade or so, cases of celiac disease have been on the rise globally. Is the disease itself becoming more common, or are more people being diagnosed? A recent podcast by The People's Perspective on Medicine explores the potential surge of celiac disease with guests, Dr. Joseph Murray, MD, and Leonardo Trasande, MD, MPP. The episode also covers Covid-19, and its risks and effects in those with celiac disease, Show 1221 is called: What Explains the Recent Increase in Celiac Disease? The program explores the dramatic increase in celiac disease in the last decades, and the rise may be explained by the fact that many more people are now aware of the condition and eating gluten-free, or other facts. Dr. Murray is with the Division of Gastroenterology and Hepatology at the Mayo Clinic in Rochester, Minnesota. Dr. Murray directs a celiac disease research and clinical program focused on epidemiology, complications and mouse models of gluten sensitivity. Dr. Trasande is a professor in pediatrics, environmental medicine, and population health at New York University. He serves as Director of the Division of Environmental Pediatrics and Vice Chair for Research in the Department of Pediatrics at NYU School of Medicine. The podcast covers the topic from numerous angles, including: What Is Celiac Disease?; Diagnosing Celiac Disease; Who Gets Celiac Disease?, and Environmental Pollutants and the Increase in Celiac Disease. COVID-19 and Possible Risks Associated with Celiac Disease At about the 30 minute mark Dr. Murray discusses how COVID-19 infection can present as GI symptoms, such as diarrhea, abdominal pain, bloating, and loss of appetite. Those with celiac disease should not assume that their GI symptoms are from gluten exposure, and should consider getting tested for COVID-19. It has been shown that those with celiac disease patients have an immune system that is less responsive to vaccines, which also creates a concern about whether this will also be an issue when a COVID-19 vaccine becomes available. According to Dr. Murray, celiac disease patients also have a higher risk of pneumonia, which is of concern if it develops as a complication of COVID-19, and they also have a higher risk of shingles (herpes zoster), which might be triggered by a COVID-19 infection. Because of the additional COVID-19 risk factors mentioned, those with celiac disease should be more careful than others. Celiac disease is not considered as high a risk factor as diabetes, hypertension, and being over age 65, but those with it should consider themselves at somewhat high risk and take additional precautions, for example: Wear a mask in indoor public places at all times; Don't make unnecessary trips outside your home; Don't go into crowded shopping areas if you don't have to; Minimize your contact with people outside your household. The initial broadcast took place on July 25, 2020. The show can now be streamed online, or downloaded for free. To listed to the show: Show 1221: What Explains the Recent Increase in Celiac Disease? Join our Forum discussion on this podcast.

Celiac.com 10/21/2019 - Parents, siblings and children of people with celiac disease are not only more likely to develop the autoimmune disease, they are more likely to develop a "silent" version, which presents few or no obvious symptoms, according to the results of a recent study. Because of this, Mayo Clinic researchers are now recommending that these first-degree relatives of celiac patients undergo celiac screening. Celiac disease is an autoimmune condition that causes gut damage when those affected consume gluten, a protein in wheat, barley and rye. A strict gluten-free diet is currently the only treatment for celiac disease. The study of celiac patients and their families showed that nearly half of close relatives who received celiac blood tests were later diagnosed with the condition. Nearly all of them had atypical symptoms or no symptoms at all. These results are startling, as are the recommendations to test people who show no symptoms, just based on their close relation to known celiac patients. That's unusual, because researchers usually keep their screening efforts restricted to those who show symptoms. Current guidelines call for testing family members when children are diagnosed with celiac disease, but, until now, when adults are diagnosed, called for testing only those close relatives who show symptoms. However, the study shows a clear likelihood of celiac risk in close relatives, which led to the Mayo Clinic's recommendation to extend testing to all close family members of known celiac patients. It's important to diagnosed celiac disease as quickly as possible. Untreated celiac disease patients face an elevated risk of developing other conditions like nutritional deficiencies, anemia, osteoporosis and even lymphoma. This is really huge news, as it means that large numbers of people likely have celiac disease without even knowing it. So, if you or your loved ones know anyone with celiac disease, pass along this information. Their immediate family members should probably get screened for celiac disease. Hopefully, this study and will trigger more like it, and increase testing of asymptomatic people who are at high risk for undiagnosed celiac disease. Read more in the Mayo Clinic Proceedings, online August 22, 2019, and at Reuters.com