Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis

NCT01942447 | Unknown

• 2 other identifiers: UKT-FMTUKT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clostridium Difficile; Clostridium Difficile Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Resolution of diarrhea

  Resolution of diarrhea

  2 weeks

Secondary Outcomes (1)

• Patient acceptance

  2 weeks

Other Outcomes (1)

• Persitence of FMT

  26 weeks

Study Arms (2)

FMT

EXPERIMENTAL

FMT

Biological: FMT

Standard

ACTIVE COMPARATOR

Vancomycin

Drug: Vancomycin

Interventions

FMT BIOLOGICAL

FMT

Vancomycin DRUG

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Martin Goetz, Prof

CONTACT

martin.goetz@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med. Martin Goetz

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 16, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: October 11, 2013

Record last verified: 2013-10

Locations

DE (1)