Study of factors influencing celiac disease in infants
Celiac Disease Genomic Environmental Microbiome and Metabolomic (CDGEMM) Study
This study is trying to see how genetics and environmental factors affect the risk of celiac disease in infants who have a family member with the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | N/A to 6 Months |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT02061306 on ClinicalTrials.gov |
What this trial studies
The CDGEMM study investigates the interplay of genomic, environmental, microbiome, and metabolomic factors in the development of celiac disease (CD) among infants. It focuses on newborns with a first-degree relative diagnosed with CD, examining how genetic predispositions and environmental influences, such as birth method and antibiotic use, contribute to disease risk. The study will follow these infants until they are five years old, collecting data on their health and dietary habits to identify potential predictors of CD. By understanding these factors, the study aims to enhance early detection and prevention strategies for high-risk children.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns and infants under six months of age with a first-degree relative diagnosed with celiac disease.
Not a fit: Infants older than six months or those without a family history of celiac disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and early detection strategies for celiac disease in high-risk infants.
How similar studies have performed: Other studies have shown success in identifying genetic and environmental factors related to celiac disease, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newborns and infants less than 6 months of age who have not been introduced to solid foods (exclusive breast milk or formula diet) * First-degree relatives of patients affected with biopsy-proven CD Exclusion Criteria: * Infants older than 6 months of age * Inability or unwillingness of legal guardian/representative to give written informed consent
Where this trial is running
Boston, Massachusetts and 1 other locations
- MassGeneral Hospital for Children — Boston, Massachusetts, United States (Recruiting)
- University of Roma La Sapienza — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Alessio Fasano, MD — Massachusetts General Hospital
- Study coordinator: Victoria Kenyon, MHA
- Email: vakenyon@mgb.org
- Phone: 617-643-4366
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.