Recruiting

Inflammatory Bowel Disease

Sponsor:

Seattle Children's Hospital

Code:

NCT07791862

Conditions

Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)

Crohn Disease (CD)

Ulcerative Colitis (UC)

Eligibility Criteria

Sex: All

Age: 0 - 55

Healthy Volunteers: Accepted

Study Details

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)

Study ID

NCT07791862

Start date

Mar 26, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2036

Anticipated

Primary completion date

Feb, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

7000 participants

Anticipated

Interventions and Outcome Measures

Arms

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. ]
  • Change in stool-based biomarkers associated with future IBD diagnosis [ 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 and Locations

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Principal Investigator:

David Suskind, MD

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2026-08-28.