Status:
TERMINATED
IMT for Primary Clostridium Difficile Infection
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
University of Oslo
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 microbiot...
Detailed Description
Up to one third of patients with clostridium difficile infection treated with antibiotics experience recurrent or relapsing symptoms within a few weeks. Even with subsequent antibiotic treatment, mult...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2017
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02301000
Start Date
February 22 2015
End Date
November 16 2017
Last Update
September 22 2020
Active Locations (7)
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1
Vestre Viken HF, Bærum Hospital
Sandvika, Gjettum, Norway, 1346
2
Sørlandet Hospital HF
Kristiansand, Norway
3
Diakonhjemmet Hospital
Oslo, Norway
4
Lovisenberg sykehus
Oslo, Norway