- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05652491
The Role of Gut Microbiome in Predicting Comorbidities and Complications in Children With Inflammatory Bowel Disease
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.
...
Study Overview
Status
Detailed 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.
Study Type
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Allergy and Infectious Diseases (NIAID)
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Virginia
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Falls Church, Virginia, United States, 22066
- Inova Fairfax Medical Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
Patients 0<=21 years of age undergoing colonoscopy will be approached for enrollment in this study.
EXCLUSION CRITERIA:
Participants carrying known diagnosis of IBD, including Crohn's disease, Ulcerative Colitis or IBD-Unspecified. However, patients with IBD suspected prior to colonoscopy can be included.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Control
Subjects who are not diagnosed with IBD
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IBD Patients
New onset, treatment-naive pediatric IBD patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
differences in fecal/intestinal microbiome
Time Frame: at diagnosis
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Determine differences in fecal/intestinal microbiome of patients IBD as compared to controls
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at diagnosis
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differences in fecal microbiome diversity and composition
Time Frame: longitudinal throughout follow up
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Determine differences in fecal microbiome diversity and composition in children with IBD with and without comorbidities
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longitudinal throughout follow up
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microbiome signatures for newly diagnosed IBD patients
Time Frame: longitudinal throughout follow up
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Determine if microbiome signatures for newly diagnosed IBD patients can predict complications and response to treatments
|
longitudinal throughout follow up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Suchitra K Hourigan, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10000909
- 000909-I
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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