Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02061306 |
| Other study ID # |
2013P001965 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2014 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Massachusetts General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
The CDGEMM study will address genomic, environmental, microbiome, and metabolomic factors
that could affect the development of CD.
Genomic: The investigators will study children who have a first degree relative with celiac
disease so that we can understand how their genes may contribute to whether they develop CD
or not. Scientists and doctors are already aware of one group of genes, called the HLA DQ2
and DQ8 genes, which are involved in the development of CD. These genes are necessary for
development of CD, but cannot alone predict who will develop the disease. The investigators
hope that the CDGEMM study will help to not only learn more about these specific genes, but
also identify other genes that could make it easier to predict who will develop CD.
Environmental: When infants enroll, the investigators will record information about their
environment including whether they were born vaginally or by Cesarean section and whether
they were given antibiotics. Over time, the investigators will also consider other parts of
the infant's medical history including feeding modality (breastfeeding versus formula
feeding), illnesses, infections, and growth to understand if any of this information is
related to CD development. Since the investigators will follow infants until they reach 5
years of age, the investigators will update this information every six months to understand
how changes might affect if the child develops CD or not.
Microbiome: Our gut, compromised of the small and large intestine, contains many types of
bacteria. These bacteria that live in the gut normally help to break down and digest food,
provide our bodies with energy, and make vitamins that our bodies need. This diverse
community of bacteria is called the gut microbiome. A main goal of the CDGEMM study is to
understand how the microbiome is affected by other factors, like foods or antibiotic drugs,
and how this may affect the development of CD. It is possible that learning about the types
of bacteria living in the gut before and after disease development may help us predict who
will develop CD before it happens.
Metabolomic: The processes that occur in our gut, such as the digestion of foods and
production of vitamins, create products that are called metabolites. The specific metabolites
that we produce differ from person to person and depend on many factors, including the genes
that we have, the members of the gut microbiome, and the foods that we eat. We will study the
infant's unique metabolomic profile (metabolites that the infant produces) to understand if
there is a specific profile associated with CD.
