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Persistent Villous Atrophy in Celiac Disease Patients Following an Intentionally Strict Gluten-free Diet

Recruitingn/aAges 20 Years - 80 YearsAllHospital Mutua de Terrassa
NCT06500754 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Celiac disease (CD) is an immune-mediated disease characterized by small intestinal inflammation from gluten ingestion, a group of proteins present in various cereals, including wheat, rye, barley, spelt, and kamut. CD is the most common chronic gastrointestinal disease and one of the most common autoimmune disorders, estimated to affect 0.4-1.7% of the general population. Currently, a strict lifelong gluten-free diet (GFD) is the only available treatment to avoid the inappropriate inflammatory response and prevent the shortening of the villi lining the small intestine (villous atrophy). However, a significant proportion of CD patients, ranging from 4% to 79%, show persistent villous atrophy despite following an intentional GFD. The causative factors and the clinical consequences of persistent villous atrophy in CD patients are not well known yet but might resemble untreated CD long-term

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age at diagnosis 18 years or more. * Diagnosis of CD with villous atrophy, positive serology and clinical and serological response to GFD. * To be in a GFD for at least 2 years, with good adherence to it. * Negative or positive anti-transglutaminase (tTG2) IgA antibodies at low titers (\<2 times the normal value) at recruitment. * Written informed consent. Exclusion Criteria: * Refractory CD (RCD) type 2 and type 1 * Other associated intestinal diseases (inflammatory bowel disease, microscopic colitis, other types of enteropathies). * Need for treatment with corticosteroids or immunosuppressants. * Surgeries or other diseases predisposing to bacterial overgrowth in the small intestine. * Pregnancy, lactation. * Associated chronic diseases (lung, heart, kidney, liver cirrhosis). * Alcoholism or drug addiction. * Schizophrenia-type psychiatric diseases, other psychoses, bipolar.
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What it tests

  • Ultra-strict gluten-free diet
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Where

1 site
Hospital Universitari MútuaTerrassa
Terrassa, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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