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Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis

NCT ID: NCT01942447

Last Updated: 2013-10-11

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-05-31

Brief Summary

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The host gastrointestinal microbiota is significantly influenced by antibiotic treatment which might favor Clostridium difficile infection (CDI), a frequent cause of community- and hospital-acquired, potentially life-threatening diarrhoea. CDI is followed by recurrence in 19-35% of patients despite adequate first line antimicrobial therapy. Currently there is no standardized therapy of recurrent or refractory CDI, but recent studies show remarkable effects of fecal microbiota transplantation (FMT).

In the current project, we aim to ideally match host and donor for FMT success in recurrent or refractory CDI. We will establish a clinical standard operating protocol for FMT, we will evaluate its safety and efficacy, and the patient acceptance and quality of life before and after FMT. We will analyse persistence of the donor microbiota within the recipient, define predictive clinical recipient and donor factors for FMT success and correlate them with microbial host and donor metagenomics.

We hypothesize that our work will yield novel, individualized strategies for recurrent or refractory CDI. In perspective, our results may be expanded to treatment of other inflammory bowel diseases.

Detailed Description

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Conditions

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Clostridium Difficile Clostridium Difficile Infection

Keywords

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Fecal microbiota transplantation microbiota clostridium difficile clostridium difficile infection Efficacy of FMT

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FMT

FMT

Group Type EXPERIMENTAL

FMT

Intervention Type BIOLOGICAL

Standard

Vancomycin

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Interventions

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FMT

Intervention Type BIOLOGICAL

Vancomycin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* recurrent or refractory CDI
* previous antimicrobial therapy includes at least on course of vancomycin 4x125 (or higher doses) for at least 7d
* CDI, defined as: 3 or more loose bowel movements/d AND (presence of C.diff. toxin in stools or toxin producing C. diff. strain) OR (endoscopic or histologic evidence of pseudomembraneous colitis)

Exclusion Criteria

* no informed consent
* no ability to provide informed consent
* immune suppression (continuous immune-suppressive drugs; steroids: prednisolone-equivalent \> 20 mg for 14d or longer)
* lack of appropriate donor
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Martin Goetz

Univ.-Prof. Dr. med. Martin Goetz

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitaetsklinikum Tuebingen

Tübingen, , Germany

Site Status

Countries

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Germany

Central Contacts

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Martin Goetz, Prof

Role: CONTACT

Email: [email protected]

Facility Contacts

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Martin Goetz, Prof.

Role: primary

Other Identifiers

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UKT

Identifier Type: OTHER

Identifier Source: secondary_id

UKT-FMT

Identifier Type: -

Identifier Source: org_study_id