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Not Yet Recruiting NCT05702879

Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success

Conditions: Ulcerative Colitis

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: 1
Enrollment: 240
Sponsor: University Hospital Inselspital, Berne

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.

Eligibility Criteria

Inclusion criteria ulcerative colitis:Signed informed consentAge 18-80 yearsGeneral ability to understand and follow study procedures, fluency in German, French, or EnglishDiagnosis of ulcerative colitis since ≥3 monthsConfirmed flare of ulcerative colitis with partial SCCAI score ≥5 points and at least one biomarker supporting intestinal inflammationPlanned start with ozanimod, steroids (prednisone ≥20mg/d or equivalent), or a biological (vedolizumab, infliximab, adalimumab, golimumab, ustekinumab)Exclusion criteria ulcerative colitisConfirmed 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 diseaseCurrent pouch or ileostomy/ colostomySevere medical, surgical, or psychiatric comorbidities interfering with study proceduresInclusion criteria controlsSigned informed consentAge 18-80 yearsGeneral ability to understand and follow study procedures, fluency in German, French, or EnglishNo 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 lossSlight symptoms (without impact onto daily activities) are permittedNo other current relevant gastrointestinal disease or condition plausibly interfering with microbiota assessment according to the discretion of the study physicianExclusion criteria controlsConfirmed cytomegalovirus (CMV) reactivation within the previous 2 weeksC. difficile related diarrhea, or other confirmed infectious diarrhea in the last 4 weeksDiagnosis of Crohn's disease, ulcerative colitisCurrent pouch or ileostomy/ colostomySevere medical, surgical, or psychiatric comorbidities interfering with study procedures

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05702879). StuddyBuddy aggregates publicly available trial information.