Inflammatory Bowel DiseasesOPTIMISTNCT06453720
Predicting IBD Treatment Outcomes With Gut Microbiome Analysis
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by University of British Columbia at 1 site in Canada.
Trial summary
The goal of this prospective observational study is to determine if specific microbiome signatures can predict therapeutic responses in adult patients with Crohn's disease (CD), a form of inflammatory bowel disease (IBD), living in British Columbia, Canada. The main questions this study seeks to answer are: 1. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2024to 1 Apr 2027
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators aim to have 75 CD patients complete phase 1 and 2, and 25 non-IBD controls to complete phase 1 only. Patient grouping for recruitment is as follows: * Group 1: 25 CD in endoscopic remission (SES-CD score <3). * Group 2: 25 CD with moderate to severe endoscopically active disease (SES-CD ≥ 7 or ≥ 4 for isolated ileal CD). * Group 3: 25 CD with mildly endoscopically active disease (SES-CD of 3-6, or 3 with isolated ileal CD). * Group 4: 25 age, sex-matched non-IBD controls.
Who may be able to join
- CD patients:
- Adult patients ≥19 years old and ≤ 80 years old.
- CD with distal small bowel and/or colonic involvement that is endoscopically assessable with colonoscopy.
- Undergoing colonoscopy as part of routine clinical care.
- Active or quiescent disease.
- Active disease will be defined as a simple endoscopic score for CD (SES-CD).
Show all 12Show fewer
- Quiescent disease is defined as an SES-CD <3.
- Mild active disease will be defined as a SES-CD of 3-6, or 3 with isolated ileal CD.
- Moderate/severe active disease will be defined as a simple endoscopic score for CD (SES-CD) ≥ 7 or ≥ 4 for isolated ileal CD.
- Non-IBD controls:
- Adult patients ≥ 19 years old and ≤ 80 years old.
- Undergoing colonoscopy as part of colorectal screening.
Who cannot join
- CD patients:
- Active perianal CD - defined as collection on MRI or clinically active fistula (i.e., draining fistula).
- Proximal small bowel (defined as not endoscopically assessable by colonoscopy) or isolated upper GI CD.
- Colectomy or Proctocolectomy.
- Pouch, J-Pouch or Reversed pouch surgery.
- Short Bowel Syndrome (SBS) diagnosis.
Show all 19Show fewer
- Antibiotics in the last 2 months for any indication.
- Gastroenteritis or travel outside of Canada and the United States in the last month.
- Colorectal cancer, high-grade dysplasia or a polyp ≥2cm diagnosed at baseline endoscopy.
- Pregnant or breastfeeding.
- Bowel resection within the preceding 4 months.
- Primary sclerosing cholangitis.
- Non-IBD controls:
- Found to have inflammation (deemed by endoscopist) at colonoscopy.
- History of IBD in 1st degree relative.
- Antibiotics in the last 2 months.
- Gastroenteritis or travel outside of Canada and the United States in the last month.
- Pregnant or breastfeeding.
- Previous bowel surgeries.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
GI Research Institute
Vancouver, British Columbia, V6Z 2K5
Pedram Tavakoli, BSc
Micah Ten-Pow, BSc
About this study
Official title: Optimizing Patient Treatment Involving Microbiome Integration for Specialized Therapeutics
The goal of this prospective observational study is to determine if specific microbiome signatures can predict therapeutic responses in adult patients with Crohn's disease (CD), a form of inflammatory bowel disease (IBD), living in British Columbia, Canada. The main questions this study seeks to answer are:
- Can microbiome signatures across different sample types (fecal, intestinal washings, and intestinal epithelial biopsies) predict response to therapy in CD?
- How do microbiome profiles differ between active and quiescent CD and non-IBD controls?
Read more
Researchers will compare microbiome signatures in patients with active and inactive CD as well as non-IBD controls to see if there are any microbial signatures that predict response to therapy.
Participants will:
- Provide fecal and blood samples.
- Undergo intestinal washings and intestinal epithelial biopsy specimens taken during routine colonoscopy.
- Participate in a longitudinal follow-up over 12 months to monitor clinical, biochemical, and endoscopic responses to therapy.
Read the detailed description
Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory condition affecting the gastrointestinal (GI) tract. The study aims to evaluate microbiome profiles (bacteriome, and mycobiome) across three different sample types (fecal, intestinal washings, and intestinal epithelial biopsies) in a cohort of adult patients with Crohn's disease (CD) living in British Columbia, Canada, and investigate whether a microbial signature may predict response to IBD therapy.
Aims:
- Determine microbiome signatures, across different sample types, in quiescent and active disease for patients with CD living in BC, Canada.
- Evaluate whether fecal, mucosal, and/or intestinal epithelial biopsy microbiome signatures can predict response to therapy.
Methods
Study Design:
Phase 1: A cross-sectional pilot study to evaluate the microbiome in patients with IBD (with active and quiescent disease) and in non-IBD controls.
Primary Outcome: Compare results of microbial analyses (including bacteriome and mycobiome) across three different sample types: intestinal washings and intestinal epithelial biopsy specimens taken during colonoscopy, as well as fecal samples.
Secondary Outcomes: Investigate correlations between the microbial analyses across different sample types and disease activity in CD. Compare the difference in microbial analyses within each sample type between active and quiescent CD as well as non-IBD patients. Investigate if fecal microbiome composition and function 2 weeks after bowel preparation is comparable to pre-bowel preparation fecal microbiome in a subset of patients with CD.
Phase 2: A longitudinal observational study with a 12-month follow-up.
Primary Outcome: Identify if there are any microbial signatures that predict response to therapy in patients with active disease requiring escalated therapy, assessed clinically and biochemically after induction (12-16 weeks) and at 12 months (+/- 3 months).
Secondary Outcomes: Compare the sensitivity and specificity of microbial analyses from each sample type in predicting response to therapy.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease
- Being tested
- Colonoscopy
- Keywords
- IBD, Crohn Disease, Biologic Therapy, Immunology, Gastrointestinal Tract
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
A colonoscopy will be performed as part of routine clinical care for all participants, with the study not requiring any additional scheduling commitments outside of routine care.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Crohn's disease | The study will include 75 consenting patients with Crohn's disease, varying in levels of severity depending on assigned SES-CD scoring from their gastroenterologist. These patients will be undergoing routine colonoscopy as per their normal care routine, with this study not requiring additional scheduling commitments. Blood, mucosal washing, and intestinal biopsy samples will be collected during routine colonoscopy procedure. The patient will have the option to collect a stool sample the day before their colonoscopy and bring it to their appointment. They will also receive a sample collection kit during their appointment to collect their next required stool sample in two weeks after their scope. Receives: Procedure: Colonoscopy | |
| Patients without inflammatory bowel disease | The study will include 25 non-IBD age and sex-matched controls to compare data alongside the CD patients. These patients will be undergoing routine colonoscopy as per their normal colon screening routine, with this study not requiring additional scheduling commitments. Blood, mucosal washing, and intestinal biopsy samples will be collected during routine colonoscopy procedure. The patient will have the option to collect a stool sample the day before their colonoscopy and bring it to their appointment. They will also receive a sample collection kit during their appointment to collect their next required stool sample in two weeks after their scope. Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare results of microbial analyses (including bacteriome and mycobiome) across three different sample types: intestinal washings and intestinal epithelial biopsy specimens taken during colonoscopy as well as fecal samples.
Microbial analyses that will be undertaken for each sample type are as follows:
Stool:
- Metagenomics (Shotgun sequencing, ITS sequencing for fungal analysis)
- Metaproteomics and metabolomics (Host, microbial, and dietary protein analysis, microbial metabolite analysis)
- Anaerobic culturing (Simulate gut environment, use dietary substrates to target key microbes)
Biopsy specimens:
- Organoid culturing (In vitro gut model analysis, epithelial-microbiome analysis, mucin production analysis)
- RNA-seq, transcriptomics (Gene expression profiling analysis, disease marker identification)
- Metagenomics
- Metaproteomics and metabolomics
Intestinal washings:
- Mucin analysis (Glycoprotein analysis)
- Metagenomics
- Metaproteomics and metabolomics
Measured: 24 months
In patients with active Crohn's disease, where a decision is made to escalate therapy after the index endoscopy, identify if there are any microbial signatures that predict response to therapy after induction (12 - 16 weeks).
- Clinical Response: Defined based on changes in clinical symptoms as per standardized clinical scoring systems (SES-CD).
- Biochemical Response: Assessed through C-reactive protein (CRP) levels and fecal calprotectin, two biomarkers that indicate inflammation or disease activity.
The Simple Endoscopy Score for Crohn's Disease (SES-CD) is an objective clinical assessment of the severity of a patient's Crohn's disease. A higher score means more severe disease activity. The three severity classes of SES-CD scoring are as follows:
- Endoscopic remission (SES-CD <3).
- Moderate to severe endoscopically active disease (SES-CD ≥ 7 or ≥ 4 for isolated ileal CD).
- Mild endoscopically active disease (SES-CD of 3-6, or 3 with isolated ileal CD).
Measured: 24 months
In patients with active Crohn's disease, where a decision is made to escalate therapy after the index endoscopy, identify if there are any microbial signatures that predict sustained response to therapy at 12 Months (+/- 3 months).
- Clinical Response: Continuation or improvement in clinical symptoms as measured by standardized clinical scoring systems (SES-CD).
- Biochemical Response: Persistent normalization or improvement in CRP levels and fecal calprotectin.
- Endoscopic Response: Improvement or healing of mucosal lesions as observed during endoscopic examination, assessed by validated clinical scoring systems (SES-CD).
Measured: 24 months
Secondary outcomes (7)
Investigate the correlations between the microbial analyses across different sample types and disease activity in CD.
Correlation Analysis: Statistical measures will be used to assess the strength and direction of the relationship between microbial composition in different sample types (intestine washings, intestinal biopsy, fecal samples) and disease activity in CD.
Disease Activity Measures: Disease activity will be assessed using the modified Harvey-Bradshaw Index, biochemical markers (CRP, fecal calprotectin), and endoscopic findings (SES-CD).
Measured: 24 months
Compare the difference in microbial analyses within each sample type between active and quiescent CD as well as non-IBD patients.
Assessments:
- Microbial Diversity Metrics:
- Alpha-diversity Metrics:
- Shannon index
- Inverse Simpson diversity index
- Chao1
- These metrics will be used to compare microbial diversity within each sample type between active and quiescent CD patients, as well as non-IBD patients.
Measured: 24 months
Compare the difference in microbial analyses within each sample type between active and quiescent CD as well as non-IBD patients.
Assessments:
Differential Abundance Analysis: Differential abundance analysis will be performed using generalized linear models to identify specific microbial taxa that are significantly different between active and quiescent CD patients, and non-IBD patients within each sample type.
Measured: 24 months
Investigate, in a subset of patients with CD, if fecal microbiome composition and function 2 weeks after bowel preparation is comparable to pre-bowel preparation fecal microbiome.
Assessments:
Comparison of Microbial Composition: Beta-diversity metrics (Bray-Curtis dissimilarity, Jaccard index) and phylogenetic-dependent distance metrics (weighted and unweighted UniFrac) will be calculated, and subsequent clustering will be applied using a principal coordinate analysis (PCoA). To test for overall microbiome differences, a PERMANOVA test will be applied. The Benjamini-Hochberg method will be applied to control for the false discovery rate.
Measured: 24 months
Investigate, in a subset of patients with CD, if fecal microbiome composition and function 2 weeks after bowel preparation is comparable to pre-bowel preparation fecal microbiome.
Assessments:
Functional Analysis: Functional profiling of the microbiome will be conducted to assess if there are any changes in the metabolic pathways and functions of the microbiome between pre- and post-bowel preparation samples in the subset of CD patients.
Measured: 24 months
Compare the sensitivity of the microbial analyses from each sample type in their prediction of response to therapy.
Sensitivity of Microbial Analyses:
- Using predictive models developed from microbial and statistical analyses, the sensitivity of microbial analyses from each sample type will be evaluated.
- Sensitivity will be reported as the proportion of true positives correctly identified by the analysis.
Measured: 24 months
Compare the specificity of the microbial analyses from each sample type in their prediction of response to therapy.
Specificity of Microbial Analyses:
- Predictive models will also be used to evaluate the specificity of microbial analyses from each sample type.
- Specificity will be reported as the proportion of true negatives correctly identified by the analysis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Aug 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- IBD Centre of BC, GI Research Institute, Pacific Gastroenterology Associates
- Responsible party
- Principal investigator, Genelle Lunken, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453720
- Sponsor's protocol ID
- H23-02927
- Acronym
- OPTIMIST
- Status last verified
- Jan 2026
- First submitted
- 22 May 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Massaro CA, Meade S, Lemarie FL, Kaur G, Bressler B, Rosenfeld G, Leung Y, Williams AJ, Lunken G. Gut microbiome predictors of advanced therapy response in Crohn's disease: protocol for the OPTIMIST prospective, longitudinal, observational pilot study in Canada. BMJ Open. 2025 Mar 13;15(3):e094280. doi: 10.1136/bmjopen-2024-094280.
PubMed 40082000
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Patient Treatment Involving Microbiome Integration for Specialized Therapeutics
- ClinicalTrials.gov ID
- NCT06453720
- Acronym / sponsor ID
- OPTIMIST / H23-02927
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease
- Keywords
- IBD, Crohn Disease, Biologic Therapy, Immunology, Gastrointestinal Tract
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- IBD Centre of BC, GI Research Institute, Pacific Gastroenterology Associates
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 12 Jun 2024 (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.
The goal of this prospective observational study is to determine if specific microbiome signatures can predict therapeutic responses in adult patients with Crohn's disease (CD), a form of inflammatory bowel disease (IBD), living in British Columbia, Canada. The main questions this study seeks to answer are:
- Can microbiome signatures across different sample types (fecal, intestinal washings, and intestinal epithelial biopsies) predict response to therapy in CD?
- How do microbiome profiles differ between active and quiescent CD and non-IBD controls?
Researchers will compare microbiome signatures in patients with active and inactive CD as well as non-IBD controls to see if there are any microbial signatures that predict response to therapy.
Participants will:
- Provide fecal and blood samples.
- Undergo intestinal washings and intestinal epithelial biopsy specimens taken during routine colonoscopy.
- Participate in a longitudinal follow-up over 12 months to monitor clinical, biochemical, and endoscopic responses to therapy.
Detailed description
Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory condition affecting the gastrointestinal (GI) tract. The study aims to evaluate microbiome profiles (bacteriome, and mycobiome) across three different sample types (fecal, intestinal washings, and intestinal epithelial biopsies) in a cohort of adult patients with Crohn's disease (CD) living in British Columbia, Canada, and investigate whether a microbial signature may predict response to IBD therapy.
Aims:
- Determine microbiome signatures, across different sample types, in quiescent and active disease for patients with CD living in BC, Canada.
- Evaluate whether fecal, mucosal, and/or intestinal epithelial biopsy microbiome signatures can predict response to therapy.
Methods
Study Design:
Phase 1: A cross-sectional pilot study to evaluate the microbiome in patients with IBD (with active and quiescent disease) and in non-IBD controls.
Primary Outcome: Compare results of microbial analyses (including bacteriome and mycobiome) across three different sample types: intestinal washings and intestinal epithelial biopsy specimens taken during colonoscopy, as well as fecal samples.
Secondary Outcomes: Investigate correlations between the microbial analyses across different sample types and disease activity in CD. Compare the difference in microbial analyses within each sample type between active and quiescent CD as well as non-IBD patients. Investigate if fecal microbiome composition and function 2 weeks after bowel preparation is comparable to pre-bowel preparation fecal microbiome in a subset of patients with CD.
Phase 2: A longitudinal observational study with a 12-month follow-up.
Primary Outcome: Identify if there are any microbial signatures that predict response to therapy in patients with active disease requiring escalated therapy, assessed clinically and biochemically after induction (12-16 weeks) and at 12 months (+/- 3 months).
Secondary Outcomes: Compare the sensitivity and specificity of microbial analyses from each sample type in predicting response to therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Crohn's disease | – | Procedure: ColonoscopyThe study will include 75 consenting patients with Crohn's disease, varying in levels of severity depending on assigned SES-CD scoring from their gastroenterologist. These patients will be undergoing routine colonoscopy as per their normal care routine, with this study not requiring additional scheduling commitments. Blood, mucosal washing, and intestinal biopsy samples will be collected during routine colonoscopy procedure. The patient will have the option to collect a stool sample the day before their colonoscopy and bring it to their appointment. They will also receive a sample collection kit during their appointment to collect their next required stool sample in two weeks after their scope. |
| Patients without inflammatory bowel disease | – | Procedure: ColonoscopyThe study will include 25 non-IBD age and sex-matched controls to compare data alongside the CD patients. These patients will be undergoing routine colonoscopy as per their normal colon screening routine, with this study not requiring additional scheduling commitments. Blood, mucosal washing, and intestinal biopsy samples will be collected during routine colonoscopy procedure. The patient will have the option to collect a stool sample the day before their colonoscopy and bring it to their appointment. They will also receive a sample collection kit during their appointment to collect their next required stool sample in two weeks after their scope. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators aim to have 75 CD patients complete phase 1 and 2, and 25 non-IBD controls to complete phase 1 only. Patient grouping for recruitment is as follows: * Group 1: 25 CD in endoscopic remission (SES-CD score <3). * Group 2: 25 CD with moderate to severe endoscopically active disease (SES-CD ≥ 7 or ≥ 4 for isolated ileal CD). * Group 3: 25 CD with mildly endoscopically active disease (SES-CD of 3-6, or 3 with isolated ileal CD). * Group 4: 25 age, sex-matched non-IBD controls.
Key inclusion criteria (12 listed)
- Adult patients ≥19 years old and ≤ 80 years old.
- CD with distal small bowel and/or colonic involvement that is endoscopically assessable with colonoscopy.
- Undergoing colonoscopy as part of routine clinical care.
- Active or quiescent disease.
- Active disease will be defined as a simple endoscopic score for CD (SES-CD).
Key exclusion criteria (19 listed)
- Active perianal CD - defined as collection on MRI or clinically active fistula (i.e., draining fistula).
- Proximal small bowel (defined as not endoscopically assessable by colonoscopy) or isolated upper GI CD.
- Colectomy or Proctocolectomy.
- Pouch, J-Pouch or Reversed pouch surgery.
- Short Bowel Syndrome (SBS) diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyA colonoscopy will be performed as part of routine clinical care for all participants, with the study not requiring any additional scheduling commitments outside of routine care. | Procedure or surgery | Patients with Crohn's disease, Patients without inflammatory bowel disease |
Primary outcome
Compare results of microbial analyses (including bacteriome and mycobiome) across three different sample types: intestinal washings and intestinal epithelial biopsy specimens taken during colonoscopy as well as fecal samples.
Time frame: 24 months
Microbial analyses that will be undertaken for each sample type are as follows: Stool: * Metagenomics (Shotgun sequencing, ITS sequencing for fungal analysis) * Metaproteomics and metabolomics (Host, microbial, and dietary protein analysis, microbial metabolite analysis) * Anaerobic culturing (Simulate gut environment, use dietary substrates to target key microbes) Biopsy specimens: * Organoid culturing (In vitro gut model analysis, epithelial-microbiome analysis, mucin production analysis) * RNA-seq, transcriptomics (Gene expression profiling analysis, disease marker identification) * Metagenomics * Metaproteomics and metabolomics Intestinal washings: * Mucin analysis (Glycoprotein analysis) * Metagenomics * Metaproteomics and metabolomics
In patients with active Crohn's disease, where a decision is made to escalate therapy after the index endoscopy, identify if there are any microbial signatures that predict response to therapy after induction (12 - 16 weeks).
Time frame: 24 months
* Clinical Response: Defined based on changes in clinical symptoms as per standardized clinical scoring systems (SES-CD). * Biochemical Response: Assessed through C-reactive protein (CRP) levels and fecal calprotectin, two biomarkers that indicate inflammation or disease activity. The Simple Endoscopy Score for Crohn's Disease (SES-CD) is an objective clinical assessment of the severity of a patient's Crohn's disease. A higher score means more severe disease activity. The three severity classes of SES-CD scoring are as follows: * Endoscopic remission (SES-CD <3). * Moderate to severe endoscopically active disease (SES-CD ≥ 7 or ≥ 4 for isolated ileal CD). * Mild endoscopically active disease (SES-CD of 3-6, or 3 with isolated ileal CD).
In patients with active Crohn's disease, where a decision is made to escalate therapy after the index endoscopy, identify if there are any microbial signatures that predict sustained response to therapy at 12 Months (+/- 3 months).
Time frame: 24 months
* Clinical Response: Continuation or improvement in clinical symptoms as measured by standardized clinical scoring systems (SES-CD). * Biochemical Response: Persistent normalization or improvement in CRP levels and fecal calprotectin. * Endoscopic Response: Improvement or healing of mucosal lesions as observed during endoscopic examination, assessed by validated clinical scoring systems (SES-CD).
7 secondary outcomes
Investigate the correlations between the microbial analyses across different sample types and disease activity in CD.
Time frame: 24 months
Compare the difference in microbial analyses within each sample type between active and quiescent CD as well as non-IBD patients.
Time frame: 24 months
Compare the difference in microbial analyses within each sample type between active and quiescent CD as well as non-IBD patients.
Time frame: 24 months
Investigate, in a subset of patients with CD, if fecal microbiome composition and function 2 weeks after bowel preparation is comparable to pre-bowel preparation fecal microbiome.
Time frame: 24 months
Investigate, in a subset of patients with CD, if fecal microbiome composition and function 2 weeks after bowel preparation is comparable to pre-bowel preparation fecal microbiome.
Time frame: 24 months
Compare the sensitivity of the microbial analyses from each sample type in their prediction of response to therapy.
Time frame: 24 months
Compare the specificity of the microbial analyses from each sample type in their prediction of response to therapy.
Time frame: 24 months
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 20 Jan 2026.
- Derived from this study: PubMed 40082000Massaro CA, Meade S, Lemarie FL, Kaur G, Bressler B, Rosenfeld G, Leung Y, Williams AJ, Lunken G. Gut microbiome predictors of advanced therapy response in Crohn's disease: protocol for the OPTIMIST prospective, longitudinal, observational pilot study in Canada. BMJ Open. 2025 Mar 13;15(3):e094280. doi: 10.1136/bmjopen-2024-094280.
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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.
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 Diseases and Crohn Disease, run by University of British Columbia at 1 site in Canada.
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 12 inclusion and 19 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 20 Jan 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 Canada. 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 Fanny LeMarié, PhD (6044414992, flemarie@ibdcentrebc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare results of microbial analyses (including bacteriome and mycobiome) across three different sample types: intestinal washings and intestinal epithelial biopsy specimens taken during colonoscopy as well as fecal samples. (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06453720, which also lists 1 linked publication.
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 20 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.