NCT02301000

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

February 22, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2017

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

2.7 years

First QC Date

November 18, 2014

Last Update Submit

September 18, 2020

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficileIntestinal microbiota therapy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with cure without recurrence

    Absence of diarrhea and no signs of recurrent CDI within 70 days

    70 days

Secondary Outcomes (2)

  • Number of participants without diarrhea

    35 days

  • Number of participants in which there was a need to change treatment

    4 days

Other Outcomes (1)

  • Number of participants with adverse events related to CDI treatment

    1-70 days

Study Arms (2)

Intestinal microbiota therapy

EXPERIMENTAL

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

Metronidazole

ACTIVE COMPARATOR

The patients allocated to this group will receive metronidazole 400 mg t.i.d. for 10 days

Drug: Metronidazole

Interventions

Intestinal microbiota therapyBIOLOGICAL

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

Also known as: Anaerobically cultivated human intestinal microbiota
Intestinal microbiota therapy
MetronidazoleDRUG

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

Metronidazole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Vestre Viken HF, Bærum Hospital

Sandvika, Gjettum, 1346, Norway

Location

Sørlandet Hospital HF

Kristiansand, Norway

Location

Diakonhjemmet Hospital

Oslo, Norway

Location

Lovisenberg sykehus

Oslo, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Telemark Hospital HF

Skien, Norway

Location

Sykehuset i Vestfold

Tønsberg, Norway

Location

Related Publications (6)

  • van Nood E, Dijkgraaf MG, Keller JJ. Duodenal infusion of feces for recurrent Clostridium difficile. N Engl J Med. 2013 May 30;368(22):2145. doi: 10.1056/NEJMc1303919. No abstract available.

    PMID: 23718168BACKGROUND

  • Kassam Z, Lee CH, Yuan Y, Hunt RH. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Am J Gastroenterol. 2013 Apr;108(4):500-8. doi: 10.1038/ajg.2013.59. Epub 2013 Mar 19.

    PMID: 23511459BACKGROUND

  • Jorup-Ronstrom C, Hakanson A, Sandell S, Edvinsson O, Midtvedt T, Persson AK, Norin E. Fecal transplant against relapsing Clostridium difficile-associated diarrhea in 32 patients. Scand J Gastroenterol. 2012 May;47(5):548-52. doi: 10.3109/00365521.2012.672587. Epub 2012 Apr 2.

    PMID: 22468996BACKGROUND

  • Lund-Tonnesen S, Berstad A, Schreiner A, Midtvedt T. [Clostridium difficile-associated diarrhea treated with homologous feces]. Tidsskr Nor Laegeforen. 1998 Mar 10;118(7):1027-30. Norwegian.

    PMID: 9531822BACKGROUND

  • Garborg K, Waagsbo B, Stallemo A, Matre J, Sundoy A. Results of faecal donor instillation therapy for recurrent Clostridium difficile-associated diarrhoea. Scand J Infect Dis. 2010 Dec;42(11-12):857-61. doi: 10.3109/00365548.2010.499541. Epub 2010 Jul 22.

    PMID: 20662620BACKGROUND

  • Midtvedt T, Norin E, Benno P, Dahlgren AL. Response to Surawicz et al. Am J Gastroenterol. 2013 Dec;108(12):1931-2. doi: 10.1038/ajg.2013.280. No abstract available.

    PMID: 24300869BACKGROUND

MeSH Terms

Conditions

Clostridium Infections

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Michael Bretthauer, Ph.d.

    University of Oslo

    STUDY CHAIR

  • Kjetil K Garborg, MD, Ph.d.

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 25, 2014

Study Start

February 22, 2015

Primary Completion

November 16, 2017

Study Completion

November 16, 2017

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations

NO(7)