Fecal Microbiota Transplantation in Postoperative Crohn's Disease

NCT ID: NCT04637438

Last Updated: 2022-10-27

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

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-18

Study Completion Date

2027-12-31

Brief Summary

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This pilot study aims to detect possible trends or signals suggesting efficacy of FMT on prevention of delay of POR, to determine the safety of FMT in post operative CD, and asses if a full randomised controlled trial is feasible in this setting. With microbiota analysis we aim to assess if changes in gut microbiota are related to disease course of CD after operation.

Detailed Description

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Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fecal Microbiota Transplantation

Group Type ACTIVE_COMPARATOR

Fecal Microbiota Transplantation

Intervention Type OTHER

FMT via colonoscopy

Plasebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Water infusion via colonoscopy

Interventions

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Fecal Microbiota Transplantation

FMT via colonoscopy

Intervention Type OTHER

Placebo

Water infusion via colonoscopy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Over 18 years
* Able to provide written consent
* Stricturing and/or fistulizing Crohn's disease needing ileocecal or ileal resection

Exclusion Criteria

* Pregnancy
* Active infection, abscess or fistula at the time of the first colonoscopy
* Life expectancy \<1 year
* Unable to provide written consent
* Use on antibiotics or probiotics at the time of first colonoscopy
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role collaborator

Joint Authority for Päijät-Häme Social and Health Care

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elina Jokinen

Doctor of Medical Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Elina Jokinen, PhD

Role: CONTACT

+3583311611

Facility Contacts

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Elina M Jokinen, PhD

Role: primary

Other Identifiers

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R20041

Identifier Type: -

Identifier Source: org_study_id

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