Familial Inflammatory Bowel Disease Early Risk

NCT07791862 | Recruiting

• 1 other identifier: STUDY00005545
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Inflammatory Bowel Disease; Crohn Disease; Ulcerative Colitis; Familial IBD

Outcome Measures

Primary Outcomes (2)

• 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.

  Serum antibody reactivity to microbial antigens will be measured using the Rapid Extracellular Antigen Profiling (REAP) assay. Antigen-specific antibody reactivity will be quantified as normalized REAP signal intensity (relative units). REAP signal intensity will be compared between participants who subsequently develop IBD and participants who do not develop IBD during follow-up.

  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.

• Change in stool-based biomarkers associated with future IBD diagnosis

  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.

Study Arms (1)

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

Eligibility Criteria

• Age: 0 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Asymptomatic first degree relative (FDR) (siblings or offspring) of patients with IBD aged between 0 and 55 years.

You may qualify if:

• Asymptomatic first degree relative (FDR) (siblings or offspring) of patients with CD or UC aged between 0 and 55 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples * Blood * Stool * Urine * Saliva * Tissue (if applicable)

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• David L Suskind, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cylia Abrous, BS

CONTACT

206-987-4701; cylia.abrous@seattlechildrens.org

Nuding Mason, Supervisor

CONTACT

206-987-0055; mason.nuding@seattlechildrens.org

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Gastroenterologist

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 28, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): February 1, 2036
• Study Completion (Estimated): February 1, 2036
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)