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 volunteersQualifiers
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
Family-based
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Change in stool-based biomarkers associated with future IBD diagnosis
Sponsors and contacts
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