Overview
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.
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.
Eligibility
Inclusion criteria ulcerative colitis:
- 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)
Exclusion criteria ulcerative colitis
- 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
Inclusion criteria controls
- 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
Exclusion criteria controls
- Confirmed cytomegalovirus (CMV) reactivation within the previous 2 weeks
- 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