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Familial Inflammatory Bowel Disease Early Risk
Familial Inflammatory Bowel Disease Early Risk (Fiber) Study
Who can join
Ages 0 to 55 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Asymptomatic first degree relative (FDR) (siblings or offspring) of patients with CD or UC aged between 0 and 55 years. Exclusion Criteria: * Nonviable neonates and uncertain viability neonates * Antibiotic treatment within 3 months prior to recruitment * Individuals with the presence of a known diagnosis of IBD, or symptoms suggestive of IBD * Not within the age range of 0-55 years
About the study
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.
Sponsor: Seattle Children's Hospital · Participants: 7,000 · Started: Mar 26, 2026
Contact the study team
- Cylia Abrous, BS · Phone: 206-987-4701
- Nuding Mason, Supervisor · Phone: 206-987-0055
Official record on ClinicalTrials.gov — NCT07791862
Locations in the U.S.
| Washington | Seattle Children's Hospital, Seattle |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.