MedTrace Logo

Familial Inflammatory Bowel Disease Early Risk

NCT07791862 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 7000

Last updated 2026-08-28

No results posted yet for this study

Summary

Brief Summary

The aim of the FIBER study is to identify potential triggers associated with the later development of IBD (inflammatory bowel disease) based on baseline characteristics and biosamples (blood, urine, stool, saliva, and tissue).

Aim 1: To identify clinical, demographic, and immunologic factors associated with an increased risk of developing IBD in family members of IBD patients.

This aim will investigate the role of clinical factors (e.g., age of onset, gender, and family history), demographic factors (e.g., socioeconomic status, geographical location), and immune system markers (e.g., inflammatory cytokine profiles, immune cell populations) in predicting the likelihood of family members developing IBD over time.

Aim 2: To examine dietary, environmental, and immunologic influences on the development of IBD in family members of IBD patients.

This aim will explore how dietary habits (e.g., fiber, fats, processed foods), environmental exposures (e.g., smoking, pollution, and antibiotic use), and immune responses (e.g., changes in T-cell activation, inflammatory markers) contribute to the risk of IBD in family members.

Aim 3: To analyze the multi-omic (metagenomic, transcriptomic, proteomic) cellular signatures of host and microbial signatures in family members of IBD patients and their association with IBD onset.

This aim will investigate changes in the gut microbiome and immune-related gene expression profiles (transcriptomics) in family members. Specifically, the aim will focus on how shifts in microbial composition and host immune response genes (e.g., those involved in inflammation and epithelial barrier function) correlate with an increased risk of IBD development.

Aim 4: To investigate the multi-omic (metabolomic, transcriptomic, proteomic) cellular signature of host and microbial signatures in family members to identify biomarkers predictive of IBD development.

This aim will involve examining the metabolic, protein, and transcriptomic signatures (e.g., circulating cytokines, immune receptor expression) in blood, urine, or stool samples. The study will seek to identify early biomarkers from these profiles that can predict the onset of IBD, even in asymptomatic family members.

Conditions

  • Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
  • Crohn Disease (CD)
  • Ulcerative Colitis (UC)

Sponsors & Collaborators

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • David L Suskind, MD · Seattle Children's Hospital

Eligibility

Min Age
0 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-26
Primary Completion
2036-02-29
Completion
2036-02-29

Countries

  • United States

Study Locations

More Related Trials

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 NCT07791862 on ClinicalTrials.gov