drugset / Trial / NCT02857582

Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile

NCT02857582

RandomizedParallel-groupSingle-blindTreatment

Summary

Patients who have received antibiotics and thereafter developed diarrhea are investigated for presence of Clostridium difficile toxin. Primary treatment is given with oral metronidazole/vancomycin. In case of relapse, secondary treatment is given with either cultured gut microbiota rectally or oral vancomycin in sequence. In those cases where secondary treatment with vancomycin fails cultured gut microbiota is given as final treatment. As an extension treatment, all failures were treated with cluttered gut microbiota through the upper route. In both cases As an alternative cultured gut microbiota may be given via the duodenal route. Follow-up is carried out after 7, 30 and 90 days with interview and stool collection for analysis of Clostridium difficile.

Timeline

Start
2014-10
Primary completion
2018-10
Completion
2018-12-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cultured human intestinal microbiota Unknown Rectal
Comparator Vancomycin Other / unclassified 500 mg Oral
Background Metronidazole Small molecule Oral