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The FECAL trial, Fecal therapy to Eliminate Clostridium difficile Associated Longstanding diarrhoea.

Fecal therapy to Eliminate Clostridium difficile Associated Longstanding diarrhoea.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25892
Enrollment
120
Registered
2008-01-14
Start date
2008-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

1. Clostridium difficile

Interventions

Arm 1: vancomycin 500 mg qid, 14 days
Arm 2: vancomycin 500 mg qid, 14 days, with a bowel lavage with kleanprep on the fourth day
Arm 3: vancomycin 500 mg qid 4 days, followed by a bowel lavage, followed by infusion of donor feces through a nasoduodenal tube on the fifth day.

Sponsors

Academic Medical Center Amsterdam the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient 18 years or older; 2. proven recurrence of Clostridium difficile associated diarrhoea (positive toxin test and diarrhoea defined as more than 3 loose or watery stools per day or >8 in 48 hours); 3. In previous episodes of Clostridium difficile associated diarrhoea at least one proper course of antibiotic therapy. (at least vancomycin 125 mg qid for 10 days or metronidazole 500 mg tid for 10 days).

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. life expectancy of less than three months; 3. expected longlasting immunecompromised state (CD420 mg a day) expected to be prescibed for more than 30 days; 5. Need for continuous use of antibiotic other than for treatment of Clostridium difficile infection.

Design outcomes

Primary

MeasureTime frame
Diarrhoea and Clostridium difficile toxin in stool after 10 weeks.

Secondary

MeasureTime frame
1. Diarrhoea and Clostridium difficile toxin in stool after five weeks; 2. Costs; 3. Quality of life; 4. Inflammatory markers.

Contacts

Public ContactE. Nood van

Postbus 22660 Department of Internal Medicine F4-222

clostridium@amc.nl020-5665983

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)