Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05652491 |
| Other study ID # |
10000909 |
| Secondary ID |
000909-I |
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 9, 2022 |
| Est. completion date |
May 30, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background:
Bacteria and other microorganisms that live in the intestines (the gut microbiome) play an
important role in a person s health. The gut microbiome helps to regulate the immune system
and control inflammation. Imbalances in the gut microbiome have been linked to illnesses such
as inflammatory bowel disease (IBD). People diagnosed with IBD can have serious health
problems. Researchers want to know more about how the gut microbiome affects the development
and progression of IBD in children. In this natural history study, they will compare the gut
microbiomes of healthy children with those who have IBD.
Objective:
To collect stool and samples of intestine tissue from children with and without IBD
undergoing colonoscopy.
Eligibility:
People under 21 years old who are having a colonoscopy at the Inova Health System or
Pediatric Specialists of Virginia.
Design:
Participants will fill out a questionnaire. They will answer questions about their history.
Topics may include how they were fed as infants; how they were born; and how often they took
antibiotics.
Stool and tissue samples from the intestines will be taken during the participants
colonoscopy. They may also give samples of blood and urine.
Participants may be asked to provide additional stool, blood, and urine samples. They may do
this up to 3 times per year. These samples may be collected at the clinic; they may also be
collected at home and mailed to the researchers.
If they have more colonoscopies, participants may be asked for more tissue samples.
Participants will be enrolled for up to 10 years.
...
Description:
The gut microbiome (community of microorganisms in the intestines) serves many important
roles in healthy people, including immune system regulation and anti-inflammatory functions.
A dysbiosis (imbalance) in the gut microbiome is associated with many immune mediated
diseases, including inflammatory bowel disease (IBD). The microbiome is thought to play a
central role in the development and propagation in IBD. Studies have shown that in IBD, the
gut microbiome demonstrates increased pro-inflammatory bacteria, a reduction in
anti-inflammatory bacteria and overall reduced diversity. Inflammatory bowel disease is
complicated and comes at a high burden to those affected. While affecting both children and
adults, patients diagnosed before 18 years of age often have more severe phenotypes than
those diagnosed in adulthood. Patients affected by IBD often have many complications such as
linear growth failure, decreased bone mineral indices, delayed puberty, malnutrition and need
for surgeries. At this time, we have limited ability to predict which patients will go on to
develop complications and the time points in which these may occur.
Further, there are many comorbidities present in patients with IBD including dermatologic
manifestations, hepatobiliary disease, other immune-mediated disease such as celiac disease
as well as endocrinopathies. Children with IBD and these comorbid conditions are thought to
have higher morbidity and decreased quality of life. While the gut microbiome is thought to
mediate the development of many of these diseases, there is little literature associating
clinical and microbiome drivers of those with IBD and these additional comorbidities.
Given that the microbiome may have a role in potentiating the inflammatory pathways
contributing to IBD, there is potential to identify microbial signatures to help determine
disease outcomes such as complications and response to treatment. In this study, we intend to
examine differences in the microbiome diversity and composition in children with IBD and
controls. We will then follow subjects longitudinally to determine initial microbiota
signatures and changes for those who develop comorbidities, complications and therapy
responsiveness.
We hope that by elucidating the microbiome of these children, we will have the opportunity to
better understand the pathogeneses of co-morbid diseases, ultimately enabling the development
of microbiome-based therapeutics for these conditions.
