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

NCT05652491 | Withdrawn

• 2 other identifiers: 10000909000909-I
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Keywords

Pediatrics; Crohn's Disease; Ulcerative Colitis; Microbiota; Host-Microbiome Response; Natural History

Outcome Measures

Primary Outcomes (3)

• differences in fecal/intestinal microbiome

  Determine differences in fecal/intestinal microbiome of patients IBD as compared to controls

  at diagnosis

• differences in fecal microbiome diversity and composition

  Determine differences in fecal microbiome diversity and composition in children with IBD with and without comorbidities

  longitudinal throughout follow up

• microbiome signatures for newly diagnosed IBD patients

  Determine if microbiome signatures for newly diagnosed IBD patients can predict complications and response to treatments

  longitudinal throughout follow up

Study Arms (2)

Control

Subjects who are not diagnosed with IBD

IBD Patients

New onset, treatment-naive pediatric IBD patients

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients already planned to have a colonoscopy as per their primary gastroenterologist seen at Pediatric Specialists of Virginia

You may qualify if:

• Patients 0\<=21 years of age undergoing colonoscopy will be approached for enrollment in this study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22066, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Suchitra K Hourigan, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 15, 2022
• Study Start: December 9, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Exact time frame is unknown. Will be completed as part of publication requirements.
• Access Criteria: Raw, de-identified data may be shared as part of publication. This will only be sequencing data, any other data will be compiled. No other current plans for sharing data exist.

Locations

US (2)