Predicting treatment success in ulcerative colitis using microbiota and metabolic signatures
An Early Combined Microbiota and Metabolic Signature in Ulcerative Colitis Patients Predict the Clinical Success of Anti-inflammatory Therapy
This study is trying to see if certain gut bacteria and metabolic markers can help predict how well anti-inflammatory treatments will work for people with ulcerative colitis during a flare-up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | vedolizumab, infliximab, adalimumab, golimumab, ustekinumab, prednisone |
| Locations | 1 site (Bern) |
| Trial ID | NCT05702879 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a predictive signature that combines microbiota and metabolic profiles to forecast the success of anti-inflammatory therapies in patients with ulcerative colitis (UC) experiencing a flare. The study involves a longitudinal, multi-center approach where UC patients and healthy controls will undergo extensive bio-sampling and clinical assessments. By analyzing these data, the researchers hope to identify early indicators of treatment response within four weeks of starting therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with a confirmed diagnosis of ulcerative colitis experiencing a flare and planning to start specific anti-inflammatory treatments.
Not a fit: Patients with Crohn's disease or those with recent infections such as CMV reactivation or C. difficile related diarrhea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable personalized treatment strategies for ulcerative colitis, improving patient outcomes.
How similar studies have performed: While the approach of using microbiota and metabolic signatures is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria ulcerative colitis: 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. 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) Exclusion criteria ulcerative colitis 1. Confirmed cytomegalovirus (CMV) reactivation within the previous 2 weeks (tested as part of standard medical practice at the discretion of the responsible physician) 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 Inclusion criteria controls 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 controls 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
Where this trial is running
Bern
- University Hospital Bern Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Benjamin Misselwitz, Prof. — Insel Gruppe AG, University Hospital Bern
- Study coordinator: Benjamin Misselwitz, Prof.
- Email: benjamin.misselwitz@dbmr.unibe.ch
- Phone: 31 664 0430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.