NCT07791862 Familial Inflammatory Bowel Disease Early Risk
| NCT ID | NCT07791862 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seattle Children's Hospital |
| Condition | Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) |
| Study Type | OBSERVATIONAL |
| Enrollment | 7,000 participants |
| Start Date | 2026-03-26 |
| Primary Completion | 2036-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 7,000 participants in total. It began in 2026-03-26 with a primary completion date of 2036-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
David L Suskind, MD
PRINCIPAL INVESTIGATOR
Seattle Children's Hospital
Frequently Asked Questions
Who can join the NCT07791862 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 55 Years, studying Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07791862 currently recruiting?
Yes, NCT07791862 is actively recruiting participants. Contact the research team at cylia.abrous@seattlechildrens.org for enrollment information.
Where is the NCT07791862 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT07791862 clinical trial?
NCT07791862 is sponsored by Seattle Children's Hospital. The principal investigator is David L Suskind, MD at Seattle Children's Hospital. The trial plans to enroll 7,000 participants.
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