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The Role of Gut Microbiome in Predicting Comorbidities and Complications in Children With Inflammatory Bowel Disease

NCT05652491 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-06-01

No results posted yet for this study

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.

...

Conditions

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Suchitra K Hourigan, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-09
Primary Completion
2023-05-30
Completion
2023-05-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05652491 on ClinicalTrials.gov