Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
NCT ID: NCT05702879
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
240 participants
OBSERVATIONAL
2023-09-06
2025-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Ulcerative colitis patients
Patients with a flare of ulcerative colitis who meet the inclusion criteria. 120 patients will be included.
Ozanimod
Start of standard therapy
TNF Inhibitor
Start of standard therapy
Steroids
Start of standard therapy
Vedolizumab
Start of standard therapy
Ustekinumab
Start of standard therapy
Controls
For each patient, enrollment of a healthy control individual who shares the same living conditions (e.g., spouse or roommate) is attempted
No interventions assigned to this group
Interventions
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Ozanimod
Start of standard therapy
TNF Inhibitor
Start of standard therapy
Steroids
Start of standard therapy
Vedolizumab
Start of standard therapy
Ustekinumab
Start of standard therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 18-80 years
3. General ability to understand and follow study procedures, fluency in German, French, or English
4. Diagnosis of ulcerative colitis since ≥3 months
5. Confirmed flare of ulcerative colitis with partial SCCAI score ≥5 points and at least one biomarker supporting intestinal inflammation
6. Planned start with ozanimod, steroids (prednisone ≥20mg/d or equivalent), or a biological (vedolizumab, infliximab, adalimumab, golimumab, ustekinumab)
1. Signed informed consent
2. Age 18-80 years
3. General ability to understand and follow study procedures, fluency in German, French, or English
4. No current or past diagnosis of inflammatory bowel disease (IBD)
5. 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
6. No other current relevant gastrointestinal disease or condition plausibly interfering with microbiota assessment according to the discretion of the study physician
Exclusion Criteria
2. 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)
3. Diagnosis of Crohn's disease
4. Current pouch or ileostomy/ colostomy
5. Severe medical, surgical, or psychiatric comorbidities interfering with study procedures
1. Confirmed cytomegalovirus (CMV) reactivation within the previous 2 weeks
2. C. difficile related diarrhea, or other confirmed infectious diarrhea in the last 4 weeks
3. Diagnosis of Crohn's disease, ulcerative colitis
4. Current pouch or ileostomy/ colostomy
5. Severe medical, surgical, or psychiatric comorbidities interfering with study procedures
18 Years
80 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Benjamin Misselwitz, Prof.
Role: PRINCIPAL_INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Locations
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University Hospital Bern Inselspital
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Benjamin Misselwitz, Prof.
Role: primary
Other Identifiers
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2022-02008
Identifier Type: -
Identifier Source: org_study_id