NCT02774382

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Clostridium difficile infection (CDI) is the most common nosocomial infection in the western world. CDI is associated with high morbidity and mortality and is a great burden for the health care system leading Center of Disease Control and Prevention (CDC) to identify it as one of three most important/urgent threats to public health. Despite antimicrobial treatment of CDI, 20% of the patients have recurrence of CDI. Due to a dysbiosis in the gut microbiota the antimicrobial treatment seems to be less effective. Fecal microbiota transplantation (FMT) is an alternative treatment for recurrent CDI. Studies have shown a cure rate up to 90% in patients with recurrent CDI. One alternative to FMT is rectal bacteriotherapy (RBT) which is a standardized bacterial culture made in the laboratory consisting of 12 different bacteria. RBT has never been investigated in a clinical trial. The project is a randomized controlled trial including 450 patients with recurrent CDI will be, after accepting participation, allocated to receive vancomycin alone or vancomycin followed by either FMT or RBT. The patients will be followed up for 180 days. Cure is defined as resolution of CDI symptoms 90 days after treatment.

Conditions

• Clostridium Difficile

Interventions

Type	Name	Description
DRUG	Vancomycin	Already incl. in arm description
DRUG	Fecal microbiota transplantation	Already incl. in arm description
DRUG	Rectal bacteriotherapy	Already incl. in arm description

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2016-05-17
• Last updated: 2017-09-27

Locations

2 sites across 1 country: Denmark