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IMT for Primary Clostridium Difficile Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02301000
Recruitment Status : Terminated (Slow recruitment in pilot phase. A follow-up trial is launched (NCT03796650).)
First Posted : November 25, 2014
Last Update Posted : September 22, 2020
University of Oslo
Information provided by (Responsible Party):
Kjetil Garborg, Oslo University Hospital

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 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
Actual Study Start Date : February 22, 2015
Actual Primary Completion Date : November 16, 2017
Actual Study Completion Date : November 16, 2017

Resource links provided by the National Library of Medicine

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

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.

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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02301000

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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
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Study Chair: Michael Bretthauer, Ph.d. University of Oslo
Principal Investigator: Kjetil K Garborg, MD, Ph.d. Oslo University Hospital
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Responsible Party: Kjetil Garborg, MD, PhD, Oslo University Hospital Identifier: NCT02301000    
Other Study ID Numbers: IMT CDI
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Keywords provided by Kjetil Garborg, Oslo University Hospital:
Clostridium difficile
Intestinal microbiota therapy
Additional relevant MeSH terms:
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Communicable Diseases
Clostridium Infections
Enterocolitis, Pseudomembranous
Gram-Positive Bacterial Infections
Bacterial Infections
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents