Familial Inflammatory Bowel Disease Early Risk

Part of paid clinical trials in Seattle, Washington.

Sponsor
Seattle Children's Hospital
Study ID
NCT07791862
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
0 Years - 55 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Mar 26, 2026
Status verified
Aug 2026
Primary completion
Feb 29, 2036
Completion
Feb 29, 2036

Study Design

Enrollment
7,000 participants (estimated)

Arms

  • Arm: first-degree relatives of patients with CD or UC
    Asymptomatic first degree relative (FDR) (siblings or offspring) of patients with CD aged between 0 and 55 years. Exclusion criteria for each subject population: * 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

Primary Outcome Measure

Serum antibody reactivity to microbial antigens measured using the Rapid Extracellular Antigen Profiling (REAP) assay, quantified as normalized REAP signal intensity (relative units) and assessed longitudinally. [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months, and at new IBD diagnosis. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Children's HospitalSeattleWashington98105
Cylia Abrous
[email protected]
206-987-4701
Mason Nuding
[email protected]
206-987-0055
David Suskind, MD (PRINCIPAL_INVESTIGATOR)
Hengqi Zheng, MD (SUB_INVESTIGATOR)

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