Celiac Disease Genomic Environmental Microbiome and Metabolomic Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 6
SponsorMassachusetts General Hospital

About this trial

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

Qualifiers

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

Disqualifiers

Infants older than 6 months of age

Inability or unwillingness of legal guardian/representative to give written informed consent

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

500 Participants
are grouped into 1 trial group

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

University of Roma La Sapienza

Collaborator

Università Politecnica delle Marche

Collaborator