At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile
In Brief
A Phase 2 clinical trial evaluating Cultured human intestinal microbiota, Vancomycin, and 1 other intervention for Clostridium Difficile. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Secondary treatment for C diff in replacement for regular vancomycin.
Active comparator to treatment with ACHIM
Primary treatment for C diff in all treatment arms