Status:
RECRUITING
Persistent Villous Atrophy in Celiac Disease Patients Following an Intentionally Strict Gluten-free Diet
Lead Sponsor:
Hospital Mutua de Terrassa
Conditions:
Celiac Disease
Villous Atrophy of Intestine
Eligibility:
All Genders
20-80 years
Brief Summary
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, sp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06500754
Start Date
January 1 2022
End Date
January 1 2027
Last Update
July 19 2024
Active Locations (1)
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1
Hospital Universitari MútuaTerrassa
Terrassa, Barcelona, Spain, 08221