Fecal Microbiota Transplantation in Patients With Ulcerative Colitis

Not Applicable

Withdrawn

• Conditions: Ulcerative Colitis
• Interventions: Other: Fecal microbiota transplantation

• Registration Number: NCT01961492
• Lead Sponsor: Turku University Hospital

Brief Summary

The purpose of this study is to find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative colitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Primary Completion: 2017-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-17
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• active ulcerative colitis (PUCAI 10-64) in whom fecal microbiota transplantation via colonoscope can be performed

Exclusion Criteria

• severe ulcerative colitis (PUCAI > 65)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal microbiota transplantation	Fecal microbiota transplantation	A single fecal microbiota transplantation via colonoscope as an adjunct therapy to standard medical treatment

Primary Outcome Measures

Name	Time	Method
Activity of ulcerative colitis	Within 1 year after the intervention	Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months.

Secondary Outcome Measures

Name	Time	Method
Colonic inflammation	Within 1 year after the intervention	Endoscopic Mayo score at 3 and 12 months after the intervention
Adverse events	Within 1 year after the intervention

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland