Familial Inflammatory Bowel Disease Early Risk

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-55
SponsorSeattle Children's Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Family-based

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

7,000 Participants
are grouped into 1 trial group
Group A: first-degree relatives of patients with CD or UC

Trial outcomes

Primary outcomes

1

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.

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.
2

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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