Study of genes, diet and gut bacteria in celiac disease risk
Looks at what factors raise the chance of celiac disease in infants.
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the siteAlso in 1 other country, 1 site
- Trial code
- Registry title
- Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- Mar 2014
- Expected to end
- Dec 2027
- Type of study
- Observational
- Record updated
- 30 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for newborns and babies under 6 months old who have a close family member with celiac disease. The study looks at genes, diet and gut bacteria to learn how celiac disease develops.
- Age
- Newborns and infants less than 6 months of age.
- Sex
- All sexes can join.
- Disease stage
- The baby must be a first-degree relative (parent, brother or sister) of a person with celiac disease confirmed by biopsy (a small tissue sample).
- Earlier treatment
- The baby must not have started solid foods yet. The baby must have only breast milk or formula.
Main reasons for not taking part
- Babies older than 6 months.
- The parent or legal guardian cannot or will not give written consent.
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- Infants older than 6 months of age
- Inability or unwillingness of legal guardian/representative to give written informed consent
Where in United States
Also in 1 other country, 1 site
- MassGeneral Hospital for ChildrenBoston, United StatesContact: Victoria Kenyon, MHATaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Infants with a first-degree relative with celiac disease
Infants who have a first-degree relative diagnosed with celiac disease.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Celiac Disease Genomic Environmental Microbiome and Metabolomic (CDGEMM) Study
- Plain-language title
- Study of genes, diet and gut bacteria in celiac disease riskGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Publications
- Record updated
- 30 October 2026