Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile

January 7, 2019 updated by: Per Hellström
Patients who have received antibiotics and thereafter developed diarrhea are investigated for presence of Clostridium difficile toxin. Primary treatment is given with oral metronidazole/vancomycin. In case of relapse, secondary treatment is given with either cultured gut microbiota rectally or oral vancomycin in sequence. In those cases where secondary treatment with vancomycin fails cultured gut microbiota is given as final treatment. As an extension treatment, all failures were treated with cluttered gut microbiota through the upper route. In both cases As an alternative cultured gut microbiota may be given via the duodenal route. Follow-up is carried out after 7, 30 and 90 days with interview and stool collection for analysis of Clostridium difficile.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Gävleborg
      • Gävle, Gävleborg, Sweden, 801 87
        • Gävle hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Antibiotic-induced diarrhea
  • Positive fecal analysis for Clostridium difficile toxin

Exclusion Criteria:

  • Antibiotic treatment
  • Probiotic treatment
  • Intestinal infection other than Clostridium difficile
  • Inflammatory bowel disease (Ulcerative colitis, Crohn's disease
  • Immunodeficiency (drug- och disease-related)
  • Pregnancy
  • Unable to accept endoscopic procedures
  • Unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vancomycin
Secondary treatment for relapse of Clostridium difficile infection.
Drug: Vancomycin
Active comparator to treatment with ACHIM
Drug: Metronidazole
Primary treatment for C diff in all treatment arms
Experimental: Cultured human intestinal microbiota1
Cultured intestinal microbiota is experimental treatment for relapse of Clostridium difficile infection.
Drug: Metronidazole
Primary treatment for C diff in all treatment arms
Biological: Cultured human intestinal microbiota
Secondary treatment for C diff in replacement for regular vancomycin.
Other Names:
  • Anaerobic cultured human intestinal microbiota (ACHIM)
Experimental: Cultured human intestinal microbiota2
Cultured intestinal microbiota is thirdly experimental treatment for second relapse of Clostridium difficile infection.
Drug: Metronidazole
Primary treatment for C diff in all treatment arms
Biological: Cultured human intestinal microbiota
Secondary treatment for C diff in replacement for regular vancomycin.
Other Names:
  • Anaerobic cultured human intestinal microbiota (ACHIM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normalization of stool consistency
Time Frame: 90 days
Normalization according to Bristol stool scale
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normalization of stool frequency
Time Frame: 90 days
Normalization to less than three bowel movements per day
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Per Hellström

Collaborators

Karolinska Institutet
Region Gävleborg

Investigators

  • Study Director: Hellström M Per, MD, PhD, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACHIM 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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