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
Sex
ALL
Min age
—
Max age
6 Months
Healthy volunteers
No
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
Primary outcome measure(s)
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. — 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 We will use stool samples collected over time to survey the microbial community in order to establish microbiota patterns associated with CD autoimmunity.
Trial sites (2)
Facility
City
Region
Status
MassGeneral Hospital for Children
Boston
Massachusetts
Recruiting
University of Roma La Sapienza
Rome
Italy
Recruiting
More Massachusetts General Hospital trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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