Fecal Transplantation for Primary Clostridium Difficile Infection

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.

Conditions

• Clostridium Difficile Infection

Interventions

OTHER

Fecal microbiota transplantation

50 g donor feces suspended in saline with added glycerol, administered by a enema kit.

DRUG

Vancomycin

Peroral vancomycin 125 mg q.i.d. for ten days.

Sponsors & Collaborators

• South-Eastern Norway Regional Health Authority

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Helse Nord-Trøndelag HF

  collaborator OTHER

• Vestre Viken Hospital Trust

  collaborator OTHER

• The Hospital of Vestfold

  collaborator OTHER

• Sykehuset Telemark

  collaborator OTHER_GOV

• Alesund Hospital

  collaborator OTHER

• University Hospital, Akershus

  collaborator OTHER

• Lovisenberg Diakonale Hospital

  collaborator OTHER

• Sorlandet Hospital HF

  collaborator OTHER_GOV

• Ostfold Hospital Trust

  collaborator OTHER

• Diakonhjemmet Hospital

  collaborator OTHER

• Nordlandssykehuset HF

  collaborator OTHER

• Sykehuset Innlandet HF

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Michael Bretthauer, MD, PhD · Oslo Universitetssykehus HF, Rikshospitalet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-17

Primary Completion

2024-04-02

Completion

2024-04-02

Countries

• Norway

Study Locations