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IMT for Primary Clostridium Difficile Infection

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ClinicalTrials.gov Identifier: NCT02301000
Recruitment Status : Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Kjetil Garborg, Oslo University Hospital

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Biological: Intestinal microbiota therapy Drug: Metronidazole Phase 2 Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intestinal Microbiota Therapy Versus Metronidazole for Primary Clostridium Difficile Infection: a Randomized Controlled Trial
Study Start Date : February 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Intestinal microbiota therapy
The patients allocated to this group will receive 60 ml of the anaerobically cultivated human intestinal microbiota through a rectal catheter.
 Biological: Intestinal microbiota therapy
60 ml of ACHIM suspension will be administered through a rectal tube
Other Name: Anaerobically cultivated human intestinal microbiota
Active Comparator: Metronidazole
The patients allocated to this group will receive metronidazole 400 mg t.i.d. for 10 days
 Drug: Metronidazole
Peroral metronidazole 400 mg t.i.d. for ten days


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with cure without recurrence [ Time Frame: 70 days ]
    Absence of diarrhea and no signs of recurrent CDI within 70 days


Secondary Outcome Measures :
  1. Number of participants without diarrhea [ Time Frame: 35 days ]
    Absence of diarrhea

  2. Number of participants in which there was a need to change treatment [ Time Frame: 4 days ]
    In the case of primary treatment failure, a change of treatment strategy will be considered according to current guidelines.


Other Outcome Measures:
  1. Number of participants with adverse events related to CDI treatment [ Time Frame: 1-70 days ]
    Patients will be contacted at 4, 35 and 70 days to identify any adverse events related to the treatment. Patients can contact a study representative at any time in case of suspected adverse events.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301000


Locations
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Norway
Vestre Viken HF, Bærum Hospital
Sandvika, Gjettum, Norway, 1346
Sørlandet Hospital HF
Kristiansand, Norway
Diakonhjemmet Hospital
Oslo, Norway
Lovisenberg sykehus
Oslo, Norway
Oslo University Hospital
Oslo, Norway
Telemark Hospital HF
Skien, Norway
Sykehuset i Vestfold
Tønsberg, Norway
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
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Study Chair: Michael Bretthauer, Ph.d. University of Oslo
Principal Investigator: Kjetil K Garborg, MD, Ph.d. Oslo University Hospital
More Information
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Publications:

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Responsible Party: Kjetil Garborg, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02301000     History of Changes
Other Study ID Numbers: IMT CDI
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Keywords provided by Kjetil Garborg, Oslo University Hospital:
Clostridium difficile
Intestinal microbiota therapy

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
 Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents