A randomised controlled trial comparing FMT (Fecal Microbiota Transplantation) after budesonide or placebo in patients with active ulcerative colitis
- Conditions
- lcerative colitis
- Registration Number
- NL-OMON20218
- Lead Sponsor
- Vedanta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Patients > 18 years old (n=24) with mild or moderate activity of ulcerative colitis despite previous maintenance therapy (mesalazine, or thiopurine, or anti-TNF) with a MA YO endoscopic score of I or lI.
CMV infection, pregnancy, recent use (<6 weeks) of antibiotics, recent (<2 months) use of oral corticosteroids, current need for systematic antibiotics or prophylactic antibiotic, recent intraabdominal surgery (<3 months), signs of active active infectious gastro-enteritis/enterocolitis or signs of infectious agents in stool sample, previous surgery for UC, abnormal renal function (eGFR <30ml/min), pre-existent leucopenia or thrombopenia (leucocyte count <2,000/mm3, or platelets <90,000/mm3, liver function tests abnormalities (>2 ULN), treatment with any investigational drug in another trial within 12 weeks of randomization, previous treatment with >2 biologicals, other significant medical illness that might interfere with this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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