Celiac Disease Genomic Environmental Microbiome and Metabolomic Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT02061306
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 6 Months
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 31, 2014
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 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

Locations (1)

FacilityCityStateZIPSite coordinators
MassGeneral Hospital for ChildrenBostonMassachusetts02114
Victoria Kenyon, MHA
[email protected]
617-643-4366
Alessio Fasano, MD (PRINCIPAL_INVESTIGATOR)
Maureen M. Leonard, MD (SUB_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Celiac disease
By specialty
GastroenterologyAutoimmune disease
By research site
MassGeneral Hospital for Children· Boston, MA

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