A randomised controlled trial comparing FMT (fecal microbiota transplantation) after budesonide or placebo in patients with active ulcerative colitis: ;Acronym: the FECBUD trial

Completed

• Conditions: inflammatory bowel disease; ulcerative colitis; 10017969

• Registration Number: NL-OMON49003
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-05-13
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• 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 and with
written informed consent.

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 pretreated with budesonide or placebo assessed<br /><br>with metagenomics/deep sequencing of the gut microbiota. </p><br>