Study of Genomic, Environmental, Microbiome, and Metabolomic Factors in Infants at Risk for Celiac Disease

What this Trial Is About

Researchers are studying celiac disease CD, a complex condition triggered by eating gluten found in wheat, rye, and barley. This study aims to understand how genes, environmental factors, the gut microbiome, and metabolomic profiles contribute to the development of CD, especially in children at higher risk due to family history. By examining these factors, the researchers hope to find ways to better predict and prevent CD in high-risk infants. The study involves infants under 6 months old who have a first-degree relative with biopsy-confirmed celiac disease. Researchers will collect detailed information on genetics, birth method, antibiotic use, feeding method, illnesses, infections, and growth. They will regularly update this information every six months until the child reaches five years old. The study also focuses on analyzing gut bacteria and metabolites through stool samples and other biological assessments to see how these relate to disease development. Participants will be followed from infancy up to five years of age with evaluations every six months. These include microbiome sequencing from stool samples, blood tests for gut permeability and immune responses, and questionnaires about health and diet. The main outcome is to track changes in gut bacteria composition over time, particularly around gluten introduction and the potential onset of autoimmunity. Secondary outcomes include monitoring gut permeability and immune markers to understand loss of gluten tolerance. The study will help identify early signs or risk factors for CD in at-risk infants.

Celiac Disease Genomic Environmental Microbiome and Metabolomic Study