Rectal Bacteriotherapy, Fecal Microbiota Transplantation or Oral Vancomycin Treatment of Recurrent Clostridium Difficile Infections

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate if treatment with fecal microbiota transplantation or rectal bacteriotherapy is superior to standard vancomycin in patients with recurrent Clostridium Difficile infections.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvidovre University Hospital
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Verified recurrent CDI with symptoms of CDI and microbiological verification (PCR).

• Previously treated for CDI with at least 10 days of vancomycin or metronidazole.

• Be able to read and understand Danish.

Exclusion Criteria:

• Life expectancy < 3 months.

• Allergy toward vancomycin

• Other infection in the GI tract with clinical symptoms similar to CDI.

• Other illness in the GI tract with clinical symptoms similar to CDI.

• Use of antibiotics for more than 14 days treating other infections

• Planning pregnancy, pregnancy or breast feeding.

• Severe immune suppression which makes FMT/RBT relatively contraindicated