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IMT for Primary Clostridium Difficile Infection

NCT02301000 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-09-22

No results posted yet for this study

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.

Conditions

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

Intestinal microbiota therapy

60 ml of ACHIM suspension will be administered through a rectal tube

DRUG

Metronidazole

Peroral metronidazole 400 mg t.i.d. for ten days

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Michael Bretthauer, Ph.d. · University of Oslo

  • Kjetil K Garborg, MD, Ph.d. · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-22
Primary Completion
2017-11-16
Completion
2017-11-16

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02301000 on ClinicalTrials.gov