Investigating persistent villous atrophy in celiac disease patients on a strict gluten-free diet
Study of the Causes and Consequences of Persistent Villous Atrophy Despite an Intentionally Strict Gluten-free Diet in Celiac Disease Patients - Effect of an Ultra-strict Gluten-free Diet on Persistent Villous Atrophy
This study is trying to find out why some people with celiac disease still have gut problems even after sticking to a strict gluten-free diet for two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Mutua de Terrassa Academic / other |
| Locations | 1 site (Terrassa, Barcelona) |
| Trial ID | NCT06500754 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on celiac disease patients who continue to experience villous atrophy despite adhering to a strict gluten-free diet for at least two years. It aims to identify the factors contributing to this persistent condition and its potential long-term complications. Participants will be monitored for their dietary adherence and serological responses, providing insights into the relationship between diet, microbiota, and epigenetics in celiac disease. The study seeks to enhance understanding of the clinical implications of ongoing villous atrophy in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with celiac disease who have been on a strict gluten-free diet for at least two years and show signs of persistent villous atrophy.
Not a fit: Patients with refractory celiac disease or other significant gastrointestinal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for celiac disease patients who do not respond adequately to a gluten-free diet.
How similar studies have performed: While there have been studies on celiac disease and gluten-free diets, the specific focus on persistent villous atrophy in well-adhered patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Terrassa, Barcelona
- Hospital Universitari MútuaTerrassa — Terrassa, Barcelona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.