Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
ConditionCeliac Disease
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
This trial does not accept healthy volunteersQualifiers
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 population
Newborns and infants younger than 6 months who are first-degree relatives of CD patients (at least one parent or sibling affected with biopsy-proven CD) are eligible for participation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Infants with a first-degree relative with celiac disease
Trial outcomes
Primary outcomes
1
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.
We will use stool samples collected over time to survey the microbial community in order to establish microbiota patterns associated with CD autoimmunity.
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 autoimmunitySecondary outcomes
1
Change in gut permeability measured by serum zonulin levels and loss of gluten tolerance measured by increased expression of pro-inflammatory cytokines and appearance of anti-tTg antibodies.
We anticipate that timing of gluten introduction in the infant's diet will influence shift in enterotype and metatranscriptome profile with subsequent increase in gut permeability and loss of gluten tolerance.
Time frame
Every six months until age 3. Every year thereafter until age 5.Other outcomes
1
Comparison of the characterization of infants' metabotypes (metabolomes) using an established and proven commercial metabolomics technology platform by Metabolon, Inc.
Our preliminary data suggest that individual metabolomic phenotypes (which are a result of gene-diet-gut microbiome interactions) can help define specific enterotypes associated to loss of gluten tolerance in infants genetically at risk of CD.
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 autoimmunitySponsors and contacts
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Massachusetts General Hospital
Lead sponsor
University of Roma La Sapienza
Collaborator
Università Politecnica delle Marche
Collaborator
Source ClinicalTrials.gov