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Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01942447
Acronym
TOCSIN
Enrollment
30
Registered
2013-09-16
Start date
2013-10-31
Completion date
2015-05-31
Last updated
2013-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile, Clostridium Difficile Infection

Keywords

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

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.

Interventions

BIOLOGICALFMT
DRUGVancomycin

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Resolution of diarrhea2 weeksResolution of diarrhea

Secondary

MeasureTime frame
Patient acceptance2 weeks

Other

MeasureTime frame
Persitence of FMT26 weeks

Countries

Germany

Contacts

Primary ContactMartin Goetz, Prof
martin.goetz@med.uni-tuebingen.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026