This is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.
The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease clinical symptoms, and severity of tissue destruction and its ability to heal in individuals with celiac disease. Information collected in the study will help researchers to generate better resources to advance celiac disease patient care.
This is a prospective, randomized, double-blind, placebo-controlled exploratory trial to evaluate the effect of L-tryptophan supplementation on celiac-related symptoms in individuals who have biopsy-confirmed celiac disease (CeD) and symptoms non-responsive to a gluten-free diet (GFD). Fifty participants, aged 18 to 75 years, who self-report persistent CeD-related symptoms despite taking a GFD for more than 1 year and who score > 40 on the Celiac Symptom Index (CSI) will be randomized to receive L-tryptophan or placebo for 3 weeks.
1. Specific Aim (1) is to assess both the immediate and longer term impact of VIRTUE on the patient's GFD knowledge compared to standard of care (SOC) dietary education. 2. Specific Aim (2) is to determine the impact of VIRTUE on patient QoL, symptomatology, and Celiac biomarkers (tissue transglutaminase antibodies, deamidated gliadin peptide IgA, deamidated gliadin peptide IgG, and total serum IgA).
Recent data show that some foods can increase intestinal mucosa permeability and immune activation of subjects with gastrointestinal (GI) symptoms. Wheat seems the most frequent food which activates this inflammatory response and can cause both GI and extra-intestinal symptoms. Patients suffering from wheat-related troubles, in absence of celiac disease diagnosis, can suffer from non-celiac wheat sensitivity (NCWS) and our previous studies showed that about 25% of them are also affected by autoimmune diseases (AD). A gluten-free diet (GFD) can influence inflammatory pattern of AD, including Sjogren's syndrome (SS). Thus, the...
Expanded access requests for AMG 714 may be considered for adult patients with biopsy proven Refractory Celiac Disease Type II who have failed all available treatment options and do not have EATL. To request access, use Responsible Party contact information provided in this record.
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