IMT for Primary Clostridium Difficile Infection

• Status: Terminated
• Trial end date: 2017-11-16
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized controlled trial to compare the effect of a 10-day course of per oral metronidazole versus a one-time rectal instillation of an anaerobically cultivated human intestinal microbiota for the treatment of a first occurrence of Clostridium difficile infection (CDI). Recurrent CDI is common after standard antibiotic treatment. We hypothesize that the instillation of a healthy intestinal microbiota will be more effective in inducing a durable cure than metronidazole for primary CDI.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborator: University of Oslo
• Treatments: Metronidazole

Criteria

Inclusion Criteria:

• Diarrhea as defined by the World Health Organization (passage of 3 or more loose or liquid stools (i.e. taking the shape of the receptacle or corresponding to Bristol stool chart types 5-7) per day, or more frequently than is normal for the individual, and

• Positive fecal test for toxigenic Clostridium difficile, and

• No evidence of CDI during the previous year.

Exclusion Criteria:

• Known presence of other stool pathogens known to cause diarrhea.

• Pregnancy and nursing.

• Patients with ongoing antibiotic treatment for other infections that cannot be stopped for at least 12 hours.

• Inflammatory bowel disease.

• Patients incapable of providing informed consent.

• Patients with <3 months life expectancy.

• Serious immunodeficiency caused by chemotherapy or other medication.

• Active immunocompromising disease.

• Patients unable to comply with protocol requirements.

• Patients in need of intensive care who are American Society of Anesthesiologists (ASA) Physical Status classification IV and V.

• Known hypersensitivity to Metronidazole