NCT02061306 Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
| NCT ID | NCT02061306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Celiac Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2014-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2014-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Celiac disease (CD) is a complex disease caused by eating gluten, a protein contained in wheat, rye, and barley. It is well known that many factors contribute to the development of CD, including the genes that you have and the foods that you eat. In the CDGEMM study, we will consider as many of these factors as possible and study how they each contribute to disease development. If the investigators find that any one factor, or combination of factors, increases the risk of developing CD, we will be able to apply this information and help prevent or detect disease in high-risk children in the future.
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
Contact & Investigator
Alessio Fasano, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT02061306 clinical trial?
This trial is open to participants of all sexes, up to 6 Months, studying Celiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02061306 currently recruiting?
Yes, NCT02061306 is actively recruiting participants. Contact the research team at vakenyon@mgb.org for enrollment information.
Where is the NCT02061306 trial being conducted?
This trial is being conducted at Boston, United States, Rome, Italy.
Who is sponsoring the NCT02061306 clinical trial?
NCT02061306 is sponsored by Massachusetts General Hospital. The principal investigator is Alessio Fasano, MD at Massachusetts General Hospital. The trial plans to enroll 500 participants.