Hypothesis: 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.
ID
Bron
Verkorte titel
Aandoening
1. Clostridium difficile;
2. Recurrent (NLD: recidiverend);
3. antibiotic associated diarrhoea;
4. diarrhoea (NLD: diarree);
5. feces (NLD: ontlasting);
6. transplantation (NLD: transplantatie).
Ondersteuning
the Netherlands
Academic Medical Center Amsterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Diarrhoea and Clostridium difficile toxin in stool after 10 weeks.
Achtergrond van het onderzoek
Recurrent 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.
Doel van het onderzoek
Hypothesis: 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.
Onderzoeksopzet
Day 1, 5, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70.
Onderzoeksproduct en/of interventie
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.
Publiek
Department of Internal Medicine
F4-222
E. Nood van
Amsterdam 1000 DD
The Netherlands
020-5665983
clostridium@amc.nl
Wetenschappelijk
Department of Internal Medicine
F4-222
E. Nood van
Amsterdam 1000 DD
The Netherlands
020-5665983
clostridium@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1135 |
| NTR-old | NTR1177 |
| Ander register | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |