Status:
TERMINATED
Fecal Transplantation for Primary Clostridium Difficile Infection
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
South-Eastern Norway Regional Health Authority
University Hospital of North Norway
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In this randomized controlled trial the investigators want to compare the effect of one-time rectal instillation of fecal microbiota transplantation, compared to a ten-day antibiotic course for the tr...
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
- Patients, ≥18 years with primary C. difficile infection, defined by the following three criteria:
- Diarrhea as defined by the WHO (≥3 loose stools per day), and
- Positive stool test for toxin producing C. difficile, and
- No evidence of previous C. difficile infection during 365 days before enrolment.
- Written informed consent
Exclusion
- Known presence of other stool pathogens known to cause diarrhea.
- Ongoing antibiotic treatment for other infections that cannot be stopped before study treatment administration.
- Inflammatory bowel disease or microscopic colitis.
- \< 3 months life expectancy.
- Serious immunodeficiency, defined as one of the following:
- Ongoing or recent chemotherapy and current or expected neutropenia with neutrophil count of \< 500/μL.
- Active severe immunocompromising disease.
- Inability to comply with protocol requirements.
- Need of intensive care.
- Known irritable bowel syndrome, diarrheal type.
- Pregnancy or nursing.
- Known or suspected toxic megacolon or ileus.
- Total or subtotal colectomy, ileostomy or colonostomy.
- Contraindications for rectal catheter insertion
- Known hypersensitivity or other contraindications to vancomycin
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2024
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03796650
Start Date
July 17 2019
End Date
April 2 2024
Last Update
September 19 2024
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Vestre Viken HF, Bærum Hospital
Sandvika, Gjettum, Norway, 1346
2
Diakonhjemmet Hospital
Oslo, Oslo County, Norway, 0319
3
Ålesund Sjukehus
Ålesund, Norway
4
Haukeland universitetssykehus
Bergen, Norway