A randomised controlled trial comparing FECal Microbiota Transplantation after BUDesonide or placebo induction in patients with ulcerative colitis; the FECBUD trial
Withdrawn
- Conditions
- inflammatory bowel diseaseulcerative colitis10017969
- Registration Number
- NL-OMON44482
- Lead Sponsor
- Haaglanden Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
patients > 18 years old (n<=24) with mild or moderate activity of ulcerative colitis despite previous maintenance therapy (mesalazine, or thiopurine, or anti-TNF, or vedolizumab) with a MAYO endoscopic subscore of I or II.
Exclusion Criteria
amongst others: pregnancy, need for (continuous) antibiotic treatment, previous prednisolon or budenofalk resistant inflammation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is engraftment of donor microbiota at 1,2, 4 and 8 weeks<br /><br>after the last FMT in patients pre-treated with budesonide or placebo assessed<br /><br>with metagenomics/deep sequencing of the gut microbiota. </p><br>
- Secondary Outcome Measures
Name Time Method