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Subjects enrolled in this study will be evaluated 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.
Celiac Disease is an autoimmune disorder that affects approximately 1% of the world's population 1. The diagnosis of CD requires clinical, histopathological and serological factors 2. Since upper gastrointestinal endoscopy allows only visualization of the small bowel up to the second part of duodenum therefore this study was designed to determine involvement of different segments of small bowel using endoscopic scale by Bonatto MW et al 3 in newly diagnosed patients of celiac disease.
To assess the efficacy and safety of AGY vs placebo when administered to individuals age 10 to 65 years with medically proven CD and on a gluten free diet
The first aim of the study is to investigate the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients. A web-based survey wil be performed and thereafter a randomized controlled trial to test the effect of a FODMAP reduction in patients with celiac disease with irritable bowel-like symptoms.
To assess the adherence to gluten free diet by measuring faecal and urinary gluten immunogenic peptides (GIP). This will provide an objective measure for adherence.
Recent studies have shown that FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) free diet is efficient in subjects with Irritable Bowel Syndrome (IBS). Patients with Inflammatory Bowel Diseases (IBD) and celiac disease (CD) can experience functional gastrointestinal symptoms not related to inflammation, but data about the use of low FODMAPs diet in these settings are still scarce. The aim of the present study was to evaluate the usefulness of a low FODMAPs diet in patients with IBS, non-active IBD and CD on strict gluten-free diet (GFD). A low FODMAPs diet could be a valid option to contrast abdominal symptoms in patients with IBS, non-active IBD and CD on GFD, thus improving the quality of life and the social relations.
A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).
Single Center, Randomized, Double-Blind, Placebo Controlled, Gluten Challenge Trial in Patients with Well-Controlled Celiac Disease
To assess the efficacy and safety of larazotide acetate versus placebo for the treatment of persistent abdominal symptoms in adult celiac disease patients.
This study aims to investigate the impact on being on a gluten free diet the first three years of life compared to a daily intake of a probiotic supplementation or placebo on the risk of developing celiac disease autoimmunity or celiac disease in genetically susceptible children. Study participants will be randomly allocated to one of the three study groups before the age of 4 months and will remain in that group with the corresponding intervention during the three first years of life. Regular visits to a study nurse and contact with study dietician will be scheduled. The dietician will support the families in keeping the correct diet intended for each study group.