Fecal Microbiota Transplantation in Patients With Ulcerative Colitis

NCT ID: NCT01961492

Last Updated: 2018-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fecal microbiota transplantation

A single fecal microbiota transplantation via colonoscope as an adjunct therapy to standard medical treatment

Group Type ACTIVE_COMPARATOR

Fecal microbiota transplantation

Intervention Type OTHER

A single fecal microbiota transplantation through colonoscope

Standard medical treatment

Standard medical treatment as recommended by the ECCO Guidelines of UC therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fecal microbiota transplantation

A single fecal microbiota transplantation through colonoscope

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

1 Year

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Marko Kalliomäki

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marko Kalliomäki, MD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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15881

Identifier Type: -

Identifier Source: org_study_id

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