Fecal Microbiota Transplantation in Patients With Ulcerative Colitis

N/AWithdrawnNCT01961492

Turku University Hospital

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Ulcerative Colitis

Interventions

Fecal microbiota transplantationOTHER

A single fecal microbiota transplantation through colonoscope

Eligibility

Sex: ALLMin age: 1 YearMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

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.

Time frame: Within 1 year after the intervention

Secondary Outcomes

Colonic inflammation

Change from baseline in the fecal calprotectin at 1 month, 3 months, 6 months, and 12 months.

Time frame: Within 1 year after the intervention

Colonic inflammation

Endoscopic Mayo score at 3 and 12 months after the intervention

Time frame: Within 1 year after the intervention

Adverse events

Time frame: Within 1 year after the intervention

Data from ClinicalTrials.gov

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