Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)FIBERNCT07791862
Familial Inflammatory Bowel Disease Early Risk
An observational study of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Crohn Disease (CD), run by Seattle Children's Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Crohn Disease (CD), Ulcerative Colitis (UC)
- How many people
- 7,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2026to Feb 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Asymptomatic first degree relative (FDR) (siblings or offspring) of patients with IBD aged between 0 and 55 years.
Who may be able to join
- Asymptomatic first degree relative (FDR) (siblings or offspring) of patients with CD or UC aged between 0 and 55 years.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Cylia Abrous, 206-987-4701, cylia.abrous@seattlechildrens.org
Mason Nuding, 206-987-0055, mason.nuding@seattlechildrens.org
About this study
Official title: Familial Inflammatory Bowel Disease Early Risk (Fiber) Study
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).
Read more
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.
Read the detailed description
The familial nature of IBD has long been identified. Observational studies have highlighted a positive family history of IBD as a major risk factor for developing IBD, with particularly high risk among first-degree relatives (FDRs) of patients with Crohn's disease (CD). Importantly, an additive risk increment of CD onset appears with each additional affected FDR. Therefore, individuals within families with multiple affected members, also known as multiplex families, harbor notably high risk of developing CD. Healthy individuals from multiplex families have been shown to have a higher number of risk alleles in IBD-associated genes compared with healthy individuals from the general population, with the mean number of risk alleles increasing alongside increasing numbers of affected FDRs. However, none of the genetic markers could discriminate between individuals from single-case families (so-called simplex families) and individuals from multiplex families. Thus, genetics is unlikely to represent the sole factor explaining the increased risk, raising the question of factors driving the increased risk of CD in multiplex families.
As IBD involves pathological immune responses, detailed study of disease immunology is central to understanding pathogenesis and progression. Sc-RNAseq and other novel immunological techniques provide the capability to interrogate individual cellular transcripts to determine pathogenic pathways, even within rare cellular subpopulations previously inaccessible using conventional techniques and bulk RNA-seq. The novelty of single-cell technologies compared with previous technologies such as bulk sequencing lies in the ability to detect rare subsets of cells potentially representing aberrant drivers of disease. Available single-cell omic technologies are described in a research paper. The inherent advantage of single-cell techniques has led to continued popularity in IBD research 8-22.
Previous work from the research group has shown that sc-RNAseq can detect changes in pediatric IBD gut tissue from dissociated tissue biopsies. The proposed study will use immunological assays, including single-cell omics, to investigate risk factors associated with development of IBD among family members of patients with already diagnosed IBD.
- 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
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start26 Mar 2026
- Primary completionFeb 2036 (estimated)
- Study completionFeb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Studies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Suskind, Seattle Children's Hospital
- Investigators
- David L Suskind, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791862
- Sponsor's protocol ID
- STUDY00005545
- Acronym
- FIBER
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD might not be shared since we do not have a plan yet.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial Inflammatory Bowel Disease Early Risk (Fiber) Study
- ClinicalTrials.gov ID
- NCT07791862
- Acronym / sponsor ID
- FIBER / STUDY00005545
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- Feb 2036 (estimated)
- Study completion
- Feb 2036 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The familial nature of IBD has long been identified. Observational studies have highlighted a positive family history of IBD as a major risk factor for developing IBD, with particularly high risk among first-degree relatives (FDRs) of patients with Crohn's disease (CD). Importantly, an additive risk increment of CD onset appears with each additional affected FDR. Therefore, individuals within families with multiple affected members, also known as multiplex families, harbor notably high risk of developing CD. Healthy individuals from multiplex families have been shown to have a higher number of risk alleles in IBD-associated genes compared with healthy individuals from the general population, with the mean number of risk alleles increasing alongside increasing numbers of affected FDRs. However, none of the genetic markers could discriminate between individuals from single-case families (so-called simplex families) and individuals from multiplex families. Thus, genetics is unlikely to represent the sole factor explaining the increased risk, raising the question of factors driving the increased risk of CD in multiplex families.
As IBD involves pathological immune responses, detailed study of disease immunology is central to understanding pathogenesis and progression. Sc-RNAseq and other novel immunological techniques provide the capability to interrogate individual cellular transcripts to determine pathogenic pathways, even within rare cellular subpopulations previously inaccessible using conventional techniques and bulk RNA-seq. The novelty of single-cell technologies compared with previous technologies such as bulk sequencing lies in the ability to detect rare subsets of cells potentially representing aberrant drivers of disease. Available single-cell omic technologies are described in a research paper. The inherent advantage of single-cell techniques has led to continued popularity in IBD research 8-22.
Previous work from the research group has shown that sc-RNAseq can detect changes in pediatric IBD gut tissue from dissociated tissue biopsies. The proposed study will use immunological assays, including single-cell omics, to investigate risk factors associated with development of IBD among family members of patients with already diagnosed IBD.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Asymptomatic first degree relative (FDR) (siblings or offspring) of patients with IBD aged between 0 and 55 years.
Key inclusion criteria (1 listed)
- Asymptomatic first degree relative (FDR) (siblings or offspring) of patients with CD or UC aged between 0 and 55 years.
Key exclusion criteria (4 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No. IPD might not be shared since we do not have a plan yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David L Suskind, MD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Crohn Disease (CD), run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cylia Abrous, BS (206-987-4701 ext. 74701, cylia.abrous@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.