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

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Per Hellström
• Collaborators: Karolinska Institutet; Region Gävleborg
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Metronidazole; Vancomycin

Criteria

Inclusion Criteria:

• Antibiotic-induced diarrhea

• Positive fecal analysis for Clostridium difficile toxin

Exclusion Criteria:

• Antibiotic treatment

• Probiotic treatment

• Intestinal infection other than Clostridium difficile

• Inflammatory bowel disease (Ulcerative colitis, Crohn's disease

• Immunodeficiency (drug- och disease-related)

• Pregnancy

• Unable to accept endoscopic procedures

• Unable to give informed consent