Fecal Transplantation for Primary Clostridium Difficile Infection

• Status: Recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

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 treatment of primary Clostridium difficile infection (CDI). The investigators hypothetsize that the instillation of feces from a healthy donor will be non-inferior to vancomycin in inducing a durable cure.

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

Details

• Lead Sponsor: Oslo University Hospital
• Collaborators: Alesund Hospital; Diakonhjemmet Hospital; Frontier Science & Technology Research Foundation, Inc.; Haukeland University Hospital; Helse Nord-Trøndelag HF; Levanger Hospital; Lovisenberg Diakonale Hospital; Nordland Hospital; Ostfold Hospital Trust; Sorlandet Hospital HF; South-Eastern Norway Regional Health Authority; Sykehuset Telemark; The Hospital of Vestfold; University Hospital of North Norway; University Hospital, Akershus; Vestre Viken Hospital Trust
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• Patients, ≥18 years with primary C. difficile infection, defined by the following three criteria:

1. Diarrhea as defined by the WHO (≥3 loose stools per day), and

2. Positive stool test for toxin producing C. difficile, and

3. No evidence of previous C. difficile infection during 365 days before enrolment.

• Written informed consent

Exclusion Criteria:

• 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