IMT for Primary Clostridium Difficile Infection
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
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Clostridium Difficile Infection | Biological: Intestinal microbiota therapy Drug: Metronidazole | Phase 2 Phase 3 |

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 |

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.
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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
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Drug: Metronidazole
Peroral metronidazole 400 mg t.i.d. for ten days |
- Number of participants with cure without recurrence [ Time Frame: 70 days ]Absence of diarrhea and no signs of recurrent CDI within 70 days
- Number of participants without diarrhea [ Time Frame: 35 days ]Absence of diarrhea
- 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.
- 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

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
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 |
Study Chair: | Michael Bretthauer, Ph.d. | University of Oslo | |
Principal Investigator: | Kjetil K Garborg, MD, Ph.d. | Oslo University Hospital |
Responsible Party: | Kjetil Garborg, MD, PhD, Oslo University Hospital |
ClinicalTrials.gov 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 |
Clostridium difficile Intestinal microbiota therapy |
Infection Communicable Diseases Clostridium Infections Enterocolitis, Pseudomembranous Gram-Positive Bacterial Infections Bacterial Infections Enterocolitis Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Metronidazole Anti-Infective Agents Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents |