Familial Inflammatory Bowel Disease Early Risk
Seattle Children's Hospital · NCT07791862
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 0 mo–55 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 7000
- US sites recruiting
- 1
- Study start
- March 26, 2026
- Record last updated
- August 28, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Seattle Children's Hospital
Seattle, WA 98105
Site contact: Cylia Abrous · 206-987-4701 · cylia.abrous@seattlechildrens.org
Study contacts (from the official record)
- Cylia Abrous, BS · 206-987-4701 · cylia.abrous@seattlechildrens.org
- Nuding Mason, Supervisor · 206-987-0055 · mason.nuding@seattlechildrens.org
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