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Celiac.com 02/05/2018 - TIMP-GLIA, a new nanoparticle-based celiac disease treatment currently under development by Cour Pharmaceuticals, has received Fast Track Designation from the US Food and Drug Administration (FDA). Phase 1 studies to assess the safety and tolerability of TIMP-GLIA are currently underway in the United States. TIMP-GLIA works in part by encapsulating a component of wheat within a nanoparticle. The treatment has resulted in gluten tolerance in numerous animal models. By encasing components of gluten proteins in a nanoparticle, Cour is hoping that the gluten will remain unrecognized by the body's immune system, at least until immune tolerance can be generated through non-inflammatory antigen presentation. The FDA created the fast track process to speed development, review and commercialization of drugs that target serious conditions and fill an unmet medical need. Fast Track Designation puts Cour in a "prime position to advance an innovative new approach for the treatment of Celiac Disease," said John J. Puisis, CEO of Cour Pharmaceuticals. Cour is investigating TIMP-GLIA as part of an effort to reprogram the body's immune system so patients develop a tolerance to gluten as a non-threatening substance and ultimately to reduce or reverse celiac disease without the need for immune suppressing drugs. Cour's approach is designed to work by encasing a component of wheat in a nanoparticle, and introducing that particle into a celiac disease patient. If it works as designed, the gluten will remain unrecognized by the body's immune system until tolerance can be achieved through non-inflammatory antigen presentation. The phase 1 clinical trial for TIMP-GLIA study is being conducted at centers in the United States. The objective of the study is to assess the safety and tolerability of TIMP-GLIA when administered intravenously (IV) as a single dose at ascending dose levels and as a repeat dose in subjects with celiac disease. All in all, this is another of many bold and encouraging efforts to treat or cure celiac disease that have arisen in the last few years. Look for news of success or failure over then next few years. Source: Pharmabiz.com
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Celiac.com 07/25/2016 - Celiac disease is one of the most common immune-mediated diseases. Often, a gluten-free diet does not fully control celiac symptoms and disease activity. Even though no new therapies have been approved, a growing effort, coupled with a rapidly expanding knowledge of the regulatory pathway could soon lead to new breakthroughs. A team of researchers recently reviewed the epidemiology, pathophysiology, and current treatment paradigm for celiac disease. The researchers were M Wungjiranirun, CP Kelly, and DA Leffler, both of the Division of Gastroenterology at the Celiac Center of Beth Israel Deaconess Medical Center in Boston, Massachusetts, USA. They also reviewed the major types of therapies being proposed for celiac treatment, and expounded broadly upon what is known, and what can be predicted concerning the regulatory pathway for approval of a new celiac disease treatment. In the near future, increasingly numerous and diverse therapy options will enter clinical trials. The desired result will be the first approved agents targeting celiac disease treatment outside of a gluten-free diet. The team notes that, though things like biopsies and blood tests will always be important in therapeutic clinical trials, there is not currently enough evidence to link them with improved patient outcomes, which is required as a baseline for drug approval. This means that patient-reported outcomes will likely be primary end points in Phase III celiac disease trials for some time to come. Source: Am J Gastroenterol. 2016 Jun;111(6):779-86. doi: 10.1038/ajg.2016.105. Epub 2016 Mar 29.
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Celiac.com 10/31/2014 - The relationship between the risk of celiac disease and both the age at which gluten is introduced to a child’s diet and a child’s early dietary pattern is unclear. A team of researchers set out to examine how the introduction of dietary gluten and HLA status impact the risk of celiac disease in children. The research team included Elena Lionetti, M.D., Stefania Castellaneta, M.D., Ruggiero Francavilla, M.D., Ph.D., Alfredo Pulvirenti, Ph.D., Elio Tonutti, M.D., Sergio Amarri, M.D., Maria Barbato, M.D., Cristiana Barbera, M.D., Graziano Barera, M.D., Antonella Bellantoni, M.D., Emanuela Castellano, M.D., Graziella Guariso, M.D., Maria Giovanna Limongelli, M.D., Salvatore Pellegrino, M.D., Carlo Polloni, M.D., Claudio Ughi, M.D., Giovanna Zuin, M.D., Alessio Fasano, M.D., and Carlo Catassi, M.D., M.P.H. They are variously affiliated with the Departments of Pediatrics (E.L.) and Clinical and Molecular Biomedicine (A.P.), University of Catania, the Department of Pediatrics, San Paolo Hospital (S.C.), and the Department of Developmental Biomedicine, University of Bari (R.F.), Bari, the Department of Immunopathology and Allergology, Udine Hospital, Udine (E.T.), the Department of Pediatrics, Azienda Ospedaliera IRCCS Santa Maria Nuova Hospital, Reggio Emilia (S.A.), the Department of Pediatrics, Sapienza University of Rome, Rome (M.B.), the Department of Pediatrics, University of Turin, Turin (C.B.), the Department of Pediatrics, San Raffaele Hospital (G.B.), and the Department of Pediatrics, Vittore Buzzi Children’s Hospital, Milan (G.Z.), the Department of Pediatrics, Bianchi Melacrino Morelli Hospital, Reggio Calabria (A.B.), Pediatric Gastroenterology Unit, Giannina Gaslini Institute, Genoa (E.C.), the Department of Pediatrics, University of Padua, Padua (G.G.), the Department of Pediatrics, Federico II University of Naples, Naples (M.G.L.), Pediatric Gastroenterology and Cystic Fibrosis Unit, University Hospital Gaetano Martino, Messina (S.P.), the Department of Pediatrics, Rovereto Hospital, Rovereto (Trento) (C.P.), the Department of Pediatrics, University of Pisa, Pisa (C.U.), and the Department of Pediatrics, Marche Polytechnic University, Ancona (C.C.) — all in Italy; and the Division of Pediatric Gastroenterology and Nutrition and Center for Celiac Research, MassGeneral Hospital for Children (A.F.), and the Celiac Program, Harvard Medical School (A.F., C.C.) — both in Boston. For their study, the team randomly divided 832 newborns who had first-degree relatives with celiac disease into groups that received their first dietary gluten at 6 months (group A) or 12 months (group . The team determined HLA genotype at 15 months of age, and conducted serologic screening for celiac disease at 15, 24, and 36 months, and again at 5, 8, and 10 years. Patients with positive serologic findings received intestinal biopsies. The primary focus was on rates of celiac disease autoimmunity and of overt celiac disease among the children at 5 years of age. A total of 707 children completed the 36 month trial. Of those, 553 had a standard-risk or high-risk HLA genotype and completed the study. At 2 years of age, substantially higher percentages of children in group A than in group B had celiac disease autoimmunity (16% vs. 7%, P=0.002) and overt celiac disease (12% vs. 5%, P=0.01). At 5 years of age, there were no longer significant differences between the groups in terms of autoimmunity (21% in group A and 20% in group B, P=0.59) or overt disease (16% and 16%, P=0.78 by the log-rank test). At 10 years, the risk of celiac disease autoimmunity was far higher among children with high-risk HLA than among those with standard-risk HLA (38% vs. 19%, P=0.001), as was the risk of overt celiac disease (26% vs. 16%, P=0.05). Other variables, including breast-feeding, were not associated with the development of celiac disease. So, the short take away here is that, according to this study, neither delayed introduction of gluten nor breast-feeding had any effect on celiac disease rates among at-risk infants. However, children who experienced later introduction of gluten showed a delay in the onset of disease. Lastly, the important predictor of disease was having a high-risk HLA genotype. Source: N Engl J Med 2014; 371:1295-1303October 2, 2014. DOI: 10.1056/NEJMoa1400697
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Celiac.com 03/16/2009 - Current treatment for celiac disease consists of a lifetime gluten-free diet. However, once the diagnosis is made, most people don’t really receive regular follow-up or monitoring of their treatment unless they have some obvious complaint. That’s beginning to change, and more doctors are beginning to advocate long-term celiac care, which includes regular tests to assess dietary compliance. To accomplish this goal, doctors are working to determine the best program of follow-up treatment. A team of Austrian researchers recently set out to determine which noninvasive test for celiac disease is best for assessing mucosal status in people with celiac disease. The research team was made up of doctors Andreas K. W. Vécsei, Ulrike B. Graf, and H. Vogelsang, associated with St. Anna Children's Hospital, Vienna, Austria and the Department of Gastroenterology and Hepatology, Clinic of Internal Medicine III, Medical University of Vienna, Vienna, Austria. The research team set out to clarify which noninvasive follow-up methods for testing blood serum or intestinal permeability (IPT) – best match the patient’s histology, and whether the accuracy of these tests is affected by the interval between diagnosis and follow-up affects. The team mined a computer database to compile information from adult patients, diagnosed with celiac disease between December 1989 and July 2006, who underwent follow up via biopsy, IPT, and serological testing via IgG anti-gliadin antibodies (AGA-IgG), AGA-IgA, and endomysial antibodies (EMA). They measured effectiveness of noninvasive test results based on the presence of villous atrophy upon biopsy. The team divided patients into two groups. The first, group A, comprised patients followed up within 24 months of diagnosis, and group B, comprising patients followed up after 24 months. In all, the team was able to evaluate forty-seven patients. The tests showed the following results: Lactulose/mannitol (L/M) ratio showed a sensitivity of 85% and a specificity of 46.2% for mucosal atrophy, while saccharose excretion showed a sensitivity of 60% and a specificity of 52.6%. AGA-IgA and AGA-IgG showed 15% and 20%, respectively, and both showed specificity of 100%. AGA was of limited usefulness due to low number of positive results. EMA assay was 50% sensitive and 77.8% specific. In group A (n = 23) L/M ratio performed best in terms of sensitivity (88.9%), whereas EMA achieved a higher specificity (71.4%). In group B, the sensitivity of the L/M ratio decreased to 85.7%, while the specificity of EMA increased to 91.7%. The team concluded that these results show that none of the non-invasive tests was an accurate replacement for follow-up biopsy in detecting severe mucosal damage. Until an accurate test is developed, long-term follow-up monitoring of gluten-free status in people with celiac disease will remain difficult to do reliably without biopsy. Endoscopy 2009; 41: 123-128
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(Celiac.com 05/14/2000) Some bishops conferences (e.g.: Chile) have allowed communicants to take communion in the form of consacrated wine alone. Nowadays, in some countries (the U.K. for instance), wafers made of wheat which contains only traces of gluten - and hence probably not deletereous for the celiac patient - are being made. The Vatican has allowed the use of such wafers through a statement of the Congregation for the Doctrine of Faith of June 19th, 1995. The Bishops Conference of England and Wales, for instance, has stated recently that they follow the 1995 norms on low-gluten altar breads from the Congregation for the Doctrine of the Faith. In implementing these norms, the Conference established a certificate for those affected by the coeliac condition. This is then administered in the local diocese. The following comes from the report of the English and Welsh bishops meeting of November 1997. Certificate for coeliac sufferers: At its Low Week 1996 meeting, the Bishops Conference asked that its advisory panel on the coeliac condition draw up a suitable certificate for use by those with the coeliac condition to show that they have received permission for the use of low-gluten altar breads as valid matter for the celebration of Mass. Such a certificate was approved by the Bishops Conference. Britain has one of the highest rates of the coeliac condition in the world. This certificate enables sufferers to present a low-gluten host for consecration, particularly when traveling and in regions where they are not known by the priest. Those with the condition may obtain the certificate by applying to their parish priest. - Congregation for the Doctrine of the Faith, norms concerning the use of low-gluten altar breads and mustum [non-alcoholic wine] as matter for the celebration of the Eucharist, 22 June 1995. I. Concerning permission to use low-gluten altar breads: A. This may be granted by Ordinaries to priests and laypersons affected by celiac disease, after presentation of a medical certificate. B. Conditions for the validity of the matter: 1. Special hosts quibus glutinum ablatum est are invalid matter for the celebration of the Eucharist; 2. Low-gluten hosts are valid matter, provided that they contain the amount of gluten sufficient to obtain the confection of bread, that there is no addition of foreign materials, and that the procedure for making such hosts is not such as to alter the nature of the substance of the bread. II. Concerning permission to use mustum: A. The preferred solution continues to be Communion per intinctionem, or in concelebration under the species of bread alone. B. Nevertheless, the permission to use mustum can be granted by Ordinaries to priests affected by alcoholism or other conditions which prevent the ingestion of even the smallest quantity of alcohol, after presentation of a medical certificate. C. By mustum is understood fresh juice from grapes, or juice preserved by suspending its fermentation (by means of freezing or other methods which do not alter its nature). D. In general, those who have received permission to use mustum are prohibited from presiding at concelebrated Masses. There may be some exceptions however: in the case of a Bishop or Superior General; or, with prior approval of the Ordinary, at the celebration of the anniversary of priestly ordination or other similar occasions. In these cases, the one who presides is to communicate under both the species of bread and that of mustum, while for the other concelebrants a chalice shall be provided in which normal wine is to be consecrated. E. In the very rare instances of laypersons requesting this permission, recourse must be made to the Holy See. III. Common Norms: A. The Ordinary must ascertain that the matter used conforms to the above requirements. B. Permissions are to be given only for as long as the situation continues which motivated the request. C. Scandal is to be avoided. D. Given the centrality of the celebration of the Eucharist in the life of the priest, candidates for the priesthood who are affected by celiac disease or suffer from alcoholism or similar conditions may not be admitted to Holy Orders. E. Since the doctrinal questions in this area have now been decided, disciplinary competence is entrusted to the Congregation for Divine Worship and the Discipline of the Sacraments. F. Concerned Episcopal Conferences shall report to the Congregation for Divine Worship and the Discipline of the Sacraments every two years regarding the application of these norms. Thanks are given to Tom Horwood, Esq., Catholic Media Office, The Bishops Conference of England and Wales, and to Ernesto Guifaldes, M.D. of the Pontificia Unicersidad Catolica de Chile. According to the UK Coeliac Society you can now obtain gluten-free Communion Wafers from the following: Eiren Religious Supplies Concord House Union Drive Sutton Coldfield West Midlands IB73 5TE UK
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