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

Launched by HOSPITAL MUTUA DE TERRASSA · Jul 8, 2024

Keywords

ClinConnect Summary

This clinical trial, called CADER2, is studying why some people with celiac disease (CD) still have damage to their intestines, known as villous atrophy, even after following a strict gluten-free diet (GFD). Celiac disease is a condition where eating gluten—found in foods like wheat and barley—causes inflammation in the intestines. The researchers want to understand the reasons behind this ongoing damage and explore whether an ultra-strict gluten-free diet could help these patients feel better.

To participate in the study, individuals must be at least 18 years old, have been diagnosed with celiac disease and have had villous atrophy, and have been following a gluten-free diet for at least two years. They should also have low levels of certain antibodies in their blood. Participants will undergo assessments to understand their condition better and might receive a more rigorous dietary plan to see if it improves their health. The outcomes of this trial could lead to new ways to help patients who are not responding well to the current treatment methods and improve their overall care.

Gender

ALL

Eligibility 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.