NCT02857582

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Per Hellström · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridium Difficile

Interventions

Type	Name	Description
BIOLOGICAL	Cultured human intestinal microbiota	Secondary treatment for C diff in replacement for regular vancomycin.
DRUG	Vancomycin	Active comparator to treatment with ACHIM
DRUG	Metronidazole	Primary treatment for C diff in all treatment arms

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-10-01
• Completion: 2018-12-01
• First posted: 2016-08-05
• Last updated: 2019-01-09

Locations

1 site across 1 country: Sweden