Investigating persistent villous atrophy in celiac disease patients on a strict gluten-free diet

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Universitari MútuaTerrassa
  Terrassa, Barcelona, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.