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

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Ulcerative Colitis

Treatments: Drug: Ustekinumab; Drug: TNF Inhibitor; Drug: Vedolizumab; Drug: Steroids; Drug: Ozanimod

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05702879

2022-02008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

240 participants in 2 patient groups

Ulcerative colitis patients

Description:

Patients with a flare of ulcerative colitis who meet the inclusion criteria. 120 patients will be included.

Treatment:

Drug: Steroids

Drug: Ozanimod

Drug: Ustekinumab

Drug: TNF Inhibitor

Drug: Vedolizumab

Controls

Description:

For each patient, enrollment of a healthy control individual who shares the same living conditions (e.g., spouse or roommate) is attempted