Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Launched by MASSACHUSETTS GENERAL HOSPITAL · Feb 10, 2014
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The Celiac Disease Genomic Environmental Microbiome and Metabolomic Study (CDGEMM) is a research trial aimed at understanding what causes celiac disease (CD). Celiac disease is a serious condition triggered by eating gluten, a protein found in foods like wheat, rye, and barley. This study will look at various factors—like genetics, diet, and the gut bacteria that live in our intestines—to see how they might increase the risk of developing CD. By identifying these risk factors, the researchers hope to improve ways to prevent or detect the disease, especially in children who may be more likely to develop it.
To participate in this study, you must be a newborn or infant under 6 months old who has not started eating solid foods yet, or a first-degree relative (like a parent or sibling) of someone with confirmed celiac disease. Unfortunately, infants older than 6 months or those whose guardians cannot provide consent are not eligible. If you join the study, you can expect to contribute to important research that may help future generations by providing insights into celiac disease and how to manage it better.
Gender
ALL
Eligibility 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
About Massachusetts General Hospital
Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Rome, , Italy
Boston, Massachusetts, United States
Patients applied
Trial Officials
Alessio Fasano, MD
Principal Investigator
Massachusetts General Hospital
Maureen M. Leonard, MD
Study Chair
Massachusetts General Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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