Recruiting

Celiac Disease

Sponsor:

Massachusetts General Hospital

Code:

NCT02061306

Conditions

Celiac Disease

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Celiac Disease

Study ID

NCT02061306

Start date

Mar, 2014

Status verified date

Oct, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Infants with a first-degree relative with celiac disease

Infants who have a first-degree relative diagnosed with celiac disease.

Primary outcome measure

  • Change in composition of the microbiota of CD in at-risk infants using culture-independent high-throughput sequence analysis of the 16S rRNA genes using the Illumina sequencing platform. [ Time Frame: Every six months through five years of age with specific focus on time of gluten introduction, time at which gluten tolerance is lost and autoimmunity develops (if applicable), and parallel time points in infants who do not go on to develop autoimmunity ]

Central Contacts and Locations

Central contacts

Victoria Kenyon, MHA

617-643-4366vakenyon@mgb.org

Locations

MassGeneral Hospital for Children

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Victoria Kenyon, MHA

617-643-4366vakenyon@mgb.org

Principal Investigator:

Maureen Leonard, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 30, 2026

Last verified

Oct, 2026

Keywords

  • Celiac disease
  • coeliac disease
  • microbiome
  • gluten
  • infants
  • pregnancy
  • genetic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.