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NCT01961492 Clinical Trial

Fecal Microbiota Transplantation in Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:
Single Fecal Microbiota Transplantation Via Colonoscope as an Adjunct Therapy in the Treatment of Ulcerative Colitis

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01961492
Other study ID # 15881
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date December 2018

Study information
Verified date October 2018
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 1 Year to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Fecal microbiota transplantation
A single fecal microbiota transplantation through colonoscope

Locations
Country Name City State
Finland Turku University Hospital Turku

Sponsors (1)
Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Activity of ulcerative colitis Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months. Within 1 year after the intervention
Secondary Colonic inflammation Change from baseline in the fecal calprotectin at 1 month, 3 months, 6 months, and 12 months. Within 1 year after the intervention
Secondary Colonic inflammation Endoscopic Mayo score at 3 and 12 months after the intervention Within 1 year after the intervention
Secondary Adverse events Within 1 year after the intervention
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