Ulcerative ColitisCOMMITNCT05702879
Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
An observational study of Ulcerative Colitis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The primary goal of the study is to develop an early (within 4 weeks) combined microbiota/metabolic signature predicting clinical response upon anti-inflammatory treatment in UC patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Ozanimod, TNF Inhibitor and Steroids
- How many people
- 240 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Sep 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients/ participants fulfilling inclusion criteria to one of the following groups will be included: 1. Patients with a flare of ulcerative colitis who meet the inclusion criteria (see above). Inclusion of 120 patients is planned. 2. Healthy controls. For each patient, a healthy control individual who shares the same living conditions (e.g., spouse or roommate) is attempted. Enrolment of controls will not be enforced but enrolment of ≥100 controls for 120 patients is expected.
Who may be able to join
- Signed informed consent
- Age 18-80 years
- General ability to understand and follow study procedures, fluency in German, French, or English
- Diagnosis of ulcerative colitis since ≥3 months
- Confirmed flare of ulcerative colitis with partial SCCAI score ≥5 points and at least one biomarker supporting intestinal inflammation
- Planned start with ozanimod, steroids (prednisone ≥20mg/d or equivalent), or a biological (vedolizumab, infliximab, adalimumab, golimumab, ustekinumab)
Show all 14Show fewer
- Signed informed consent
- Age 18-80 years
- General ability to understand and follow study procedures, fluency in German, French, or English
- No current or past diagnosis of inflammatory bowel disease (IBD)
- No current medical complaints typic for IBD e.g.
- Diarrhea, severe constipation, abdominal pain, blood in stool, weight loss
- Slight symptoms (without impact onto daily activities) are permitted
- No other current relevant gastrointestinal disease or condition plausibly interfering with microbiota assessment according to the discretion of the study physician
Who cannot join
- Confirmed cytomegalovirus (CMV) reactivation within the previous 2 weeks (tested as part of standard medical practice at the discretion of the responsible physician)
- C. difficile related diarrhea, or other confirmed infectious diarrhea in the last 4 weeks (tested as part of standard medical practice at the discretion of the responsible physician)
- Diagnosis of Crohn's disease
- Current pouch or ileostomy/ colostomy
- Severe medical, surgical, or psychiatric comorbidities interfering with study procedures
- Confirmed cytomegalovirus (CMV) reactivation within the previous 2 weeks
Show all 10Show fewer
- C. difficile related diarrhea, or other confirmed infectious diarrhea in the last 4 weeks
- Diagnosis of Crohn's disease, ulcerative colitis
- Current pouch or ileostomy/ colostomy
- Severe medical, surgical, or psychiatric comorbidities interfering with study procedures
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Bern Inselspital
Bern, 3013
Benjamin Misselwitz, Prof.
About this study
Official title: An Early Combined Microbiota and Metabolic Signature in Ulcerative Colitis Patients Predict the Clinical Success of Anti-inflammatory Therapy
The primary goal of the study is to develop an early (within 4 weeks) combined microbiota/metabolic signature predicting clinical response upon anti-inflammatory treatment in UC patients.
Read the detailed description
The investigators perform a longitudinal prospective multi-center study for ulcerative colitis (UC) patients with a flare at/and after the time of starting a new treatment and healthy household controls. They will perform intense longitudinal bio-sampling and deep clinical characterization.
With this information the aim is to develop a predictive signature regarding the success of a new ly started anti-inflammatory therapy after an UC flare.
- Conditions
- Ulcerative Colitis
- Being tested
- Ozanimod, TNF Inhibitor, Steroids, Vedolizumab, Ustekinumab
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
Start of standard therapy
TNF InhibitorDrug
Also called infliximab, adalimumab, etanercept, golimumab, and certolizumab.
Start of standard therapy
SteroidsDrug
Also called Prednisolon
Start of standard therapy
VedolizumabDrug
Start of standard therapy
UstekinumabDrug
Start of standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis patients | Patients with a flare of ulcerative colitis who meet the inclusion criteria. 120 patients will be included. Receives: Drug: Ozanimod; Drug: TNF Inhibitor; Drug: Steroids; Drug: Vedolizumab; Drug: Ustekinumab | |
| Controls | For each patient, enrollment of a healthy control individual who shares the same living conditions (e.g., spouse or roommate) is attempted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a predictive score regarding success of anti-inflammatory therapy after start of a new treatment in ulcerative colitis
The predictive microbiota signature will be developed using machine learning, considering clinical data, microbiota descriptors, and metabolic changes from day 0 to week 4 (see analysis). Clinical response will be defined as a decrease in the simple clinical colitis activity index (SCCAI) score by ≥3 points 25or to a level of ≤2.5 points 26 at 8 weeks after the start of anti-inflammatory treatment.
Measured: 4 months
Secondary outcomes (18)
Predicting clinical remission
Assessment of the microbiota/metabolic signature predicting clinical remission (SSCAI <2.5)
Measured: 8 weeks
Predicting clinical remission
Assessment of the microbiota/metabolic signature predicting clinical remission (SSCAI <2.5)
Measured: 12 weeks
Predicting clinical remission
Assessment of the microbiota/metabolic signature predicting clinical remission (SSCAI <2.5)
Measured: 6 months
Predicting clinical remission
Assessment of the microbiota/metabolic signature predicting clinical remission (SSCAI <2.5)
Measured: 12 months
Predicting calprotectin reduction
Assessment of the microbiota/metabolic signature predicting a reduction in fecal calprotectin levels
Measured: 2 weeks
Predicting calprotectin reduction
Assessment of the microbiota/metabolic signature predicting a reduction in fecal calprotectin levels
Measured: 8 weeks
Predicting calprotectin reduction
Assessment of the microbiota/metabolic signature predicting a reduction in fecal calprotectin levels
Measured: 12 weeks
Predicting calprotectin reduction
Assessment of the microbiota/metabolic signature predicting a reduction in fecal calprotectin levels
Measured: 6 months
Predicting calprotectin reduction
Assessment of the microbiota/metabolic signature predicting a reduction in fecal calprotectin levels
Measured: 12 months
Differential microbiota response to therapy: Ozanimod
Sensitivity analysis in the subgroup treated with Ozanimod in regards to differential signatures in the prediction signature
Measured: 12 months
Differential microbiota response to therapy: TNF-inhibitors
Sensitivity analysis in the subgroup treated with TNF-inhibitors in regards to differential signatures in the prediction signature
Measured: 12 months
Differential microbiota response to therapy: Vedolizumab
Sensitivity analysis in the subgroup treated with Vedolizumab in regards to differential signatures in the prediction signature
Measured: 12 months
Differential microbiota response to therapy: Ustekinumab
Sensitivity analysis in the subgroup treated with Ustekinumab in regards to differential signatures in the prediction signature
Measured: 12 months
Differential microbiota response to therapy: Steroids
Sensitivity analysis in the subgroup treated with Steroids in regards to differential signatures in the prediction signature
Measured: 12 months
Signature differences between ulcerative colitis and healthy controls
Comparison of microbiota/metabolic signatures between ulcerative colitis patients and controls using clustering and differential abundance analysis
Measured: 12 months
Metagenomic substrain assessment
Identification of substrains in patient samples using metagenomic sequencing and follow up their persistence/loss over time
Measured: 12 months
Fatigue assessment
Fatigue severity measured by the fatigue severity scale over time and assessed for reduction after therapy start
Measured: 12 months
Adverse effects
Assessment regarding potential adverse effects in relation medical therapy by screening questionnaires
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start6 Sep 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Benjamin Misselwitz, Prof., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702879
- Sponsor's protocol ID
- 2022-02008
- Acronym
- COMMIT
- Status last verified
- Nov 2023
- First submitted
- 18 Jan 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analytic code for generation of the predictive signature will be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Combined Microbiota and Metabolic Signature in Ulcerative Colitis Patients Predict the Clinical Success of Anti-inflammatory Therapy
- ClinicalTrials.gov ID
- NCT05702879
- Acronym / sponsor ID
- COMMIT / 2022-02008
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 27 Jan 2023 (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 primary goal of the study is to develop an early (within 4 weeks) combined microbiota/metabolic signature predicting clinical response upon anti-inflammatory treatment in UC patients.
Detailed description
The investigators perform a longitudinal prospective multi-center study for ulcerative colitis (UC) patients with a flare at/and after the time of starting a new treatment and healthy household controls. They will perform intense longitudinal bio-sampling and deep clinical characterization.
With this information the aim is to develop a predictive signature regarding the success of a new ly started anti-inflammatory therapy after an UC flare.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis patients | – | Drug: Ozanimod, Drug: TNF Inhibitor, Drug: Steroids, Drug: Vedolizumab, Drug: UstekinumabPatients with a flare of ulcerative colitis who meet the inclusion criteria. 120 patients will be included. |
| Controls | – | –For each patient, enrollment of a healthy control individual who shares the same living conditions (e.g., spouse or roommate) is attempted |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients/ participants fulfilling inclusion criteria to one of the following groups will be included: 1. Patients with a flare of ulcerative colitis who meet the inclusion criteria (see above). Inclusion of 120 patients is planned. 2. Healthy controls. For each patient, a healthy control individual who shares the same living conditions (e.g., spouse or roommate) is attempted. Enrolment of controls will not be enforced but enrolment of ≥100 controls for 120 patients is expected.
Key inclusion criteria (14 listed)
- Signed informed consent
- Age 18-80 years
- General ability to understand and follow study procedures, fluency in German, French, or English
- Diagnosis of ulcerative colitis since ≥3 months
- Confirmed flare of ulcerative colitis with partial SCCAI score ≥5 points and at least one biomarker supporting intestinal inflammation
Key exclusion criteria (10 listed)
- Confirmed cytomegalovirus (CMV) reactivation within the previous 2 weeks (tested as part of standard medical practice at the discretion of the responsible physician)
- C. difficile related diarrhea, or other confirmed infectious diarrhea in the last 4 weeks (tested as part of standard medical practice at the discretion of the responsible physician)
- Diagnosis of Crohn's disease
- Current pouch or ileostomy/ colostomy
- Severe medical, surgical, or psychiatric comorbidities interfering with study procedures
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 |
|---|---|---|
| OzanimodStart of standard therapy | Drug | Ulcerative colitis patients |
| TNF InhibitorAlso: infliximab, adalimumab, etanercept, golimumab, and certolizumab.Start of standard therapy | Drug | Ulcerative colitis patients |
| SteroidsAlso: PrednisolonStart of standard therapy | Drug | Ulcerative colitis patients |
| VedolizumabStart of standard therapy | Drug | Ulcerative colitis patients |
| UstekinumabStart of standard therapy | Drug | Ulcerative colitis patients |
Primary outcome
Development of a predictive score regarding success of anti-inflammatory therapy after start of a new treatment in ulcerative colitis
Time frame: 4 months
The predictive microbiota signature will be developed using machine learning, considering clinical data, microbiota descriptors, and metabolic changes from day 0 to week 4 (see analysis). Clinical response will be defined as a decrease in the simple clinical colitis activity index (SCCAI) score by ≥3 points 25or to a level of ≤2.5 points 26 at 8 weeks after the start of anti-inflammatory treatment.
18 secondary outcomes
Predicting clinical remission
Time frame: 8 weeks
Predicting clinical remission
Time frame: 12 weeks
Predicting clinical remission
Time frame: 6 months
Predicting clinical remission
Time frame: 12 months
Predicting calprotectin reduction
Time frame: 2 weeks
Predicting calprotectin reduction
Time frame: 8 weeks
Predicting calprotectin reduction
Time frame: 12 weeks
Predicting calprotectin reduction
Time frame: 6 months
Predicting calprotectin reduction
Time frame: 12 months
Differential microbiota response to therapy: Ozanimod
Time frame: 12 months
Differential microbiota response to therapy: TNF-inhibitors
Time frame: 12 months
Differential microbiota response to therapy: Vedolizumab
Time frame: 12 months
Differential microbiota response to therapy: Ustekinumab
Time frame: 12 months
Differential microbiota response to therapy: Steroids
Time frame: 12 months
Signature differences between ulcerative colitis and healthy controls
Time frame: 12 months
Metagenomic substrain assessment
Time frame: 12 months
Fatigue assessment
Time frame: 12 months
Adverse effects
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Yes. Analytic code for generation of the predictive signature will be made available to other researchers
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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. This study is not recruiting at the moment.
Benjamin Misselwitz, Prof. principal investigator
Insel Gruppe AG, University Hospital Bern
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 Ulcerative Colitis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 14 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Misselwitz, Prof. (31 664 0430 ext. +41, benjamin.misselwitz@dbmr.unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a predictive score regarding success of anti-inflammatory therapy after start of a new treatment in ulcerative colitis (time frame: 4 months). 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 6 Dec 2023.