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


- candidate number2995
- NTR NumberNTR1177
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2008
- Secondary IDs 
- Public TitleThe FECAL trial, Fecal therapy to Eliminate Clostridium difficile Associated Longstanding diarrhoea.
- Scientific TitleFecal therapy to Eliminate Clostridium difficile Associated Longstanding diarrhoea.
- ACRONYMthe FECAL trial
- hypothesisHypothesis: An important factor in recurrence of Clostridium difficile associated diarrhoea is persistent disturbance of intestinal flora. With restoration of flora by feces from a healthy donor future recurrences can be prevented.
- Healt Condition(s) or Problem(s) studiedClostridium difficile
- Inclusion criteria1. 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 criteria1. Pregnancy;
2. life expectancy of less than three months;
3. expected longlasting immunecompromised state (CD4<240, cytotoxic chemotherapy);
4. Prednisolon (>20 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2008
- planned closingdate31-dec-2009
- Target number of participants120
- InterventionsArm 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.
- Primary outcomeDiarrhoea and Clostridium difficile toxin in stool after 10 weeks.
- Secondary outcome1. Diarrhoea and Clostridium difficile toxin in stool after five weeks;
2. Costs;
3. Quality of life;
4. Inflammatory markers.
- TimepointsDay 1, 5, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70.
- Trial web sitewww.fecaltrial.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. E. Nood van
- CONTACT for SCIENTIFIC QUERIESDrs. E. Nood van
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryRecurrent Clostridium difficile associated diarrhoea is an emerging problem in Hospitals and Nursing Homes throughout the western world. Clostridium difficile associated diarrhoea is thought to recur due to persisting spores and bacteria in the intestine on the one hand, and a long term disturbance of intestinal homeostasis on the other. Restoring the intestinal flora with feces from a healthy donor is believed to be effective in the prevention of recurrences. This trial is performed in which infusion of donor feces through a duodenal tube is compared with conventional antibiotic therapy, or antibiotic therapy with bowel lavage.
Endpoints are diarrhoea and Clostridium toxin in stool after 10 weeks (primary) and after 5 weeks, as well as inflammatory markers, cost and quality of life. Follow up is 10 weeks.
- Main changes (audit trail)
- RECORD14-jan-2008 - 9-apr-2008


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