Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection (EarlyFMT)

June 7, 2022 updated by: Christian Hvas

Clostridioides difficile (CD) infection (CDI) is a global health threat with an urgent need for new treatment strategies. Faecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (CDI), and is currently recommended for multiple (three or more), recurrent CDI infections. The role of FMT earlier in the treatment hierarchy of CDI remains to be determined.

In this randomized, double-blinded, placebo-controlled clinical trial, we compare FMT with placebo following standard antibiotic treatment for first or second Clostridioides difficile infection.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a parallel arm placebo-controlled clinical trial. We aim to include 84 adult patients with their first or second episode of Clostridioides difficile (formerly Clostridium difficile) infection. All patients receive vancomycin standard therapy. Patients are randomised in a 1:1 ratio to two treatments with capsules that contain either FMT+FMT or placebo+placebo. The primary outcome is absence of C difficile-associated disease 8 weeks after randomisation. Patients who have fulminant disease where it is deemed unethical to give placebo are offered open-label FMT. The primary outcome in patients with fulminant C difficile infection is 8 weeks mortality.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

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

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University 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

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. or 2. CDI (within a year) defined as: > 3 bowel movements of Bristol 6-7 per day and positive stool CD-test.
  • Age 18 years or higher.

Exclusion Criteria:

  • Pregnancy
  • Does not speak or understand the Danish language
  • Current antibiotic treatment other than vancomycin
  • Current treatment with potential interations with vancomycin
  • Allergy to vancomycin
  • Previous anaphylactic reactions due to food allergies
  • Continuous need for proton pump inhibitor
  • Documented gastroparesis
  • Fulminant CDI

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: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vancomycin 125 x 4 for 10 days + 2 Fecal Microbota Transplantation
Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, FMT.
Other: Fecal microbiota transplantion (FMT)
Single donor, fecal microbiota transplantion (FMT) from healthy human donors.
Placebo Comparator: Vancomycin 125 x 4 for 10 days + 2 Placebo
Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, placebo.
Other: Placebo
Food coloring, water, glycerol
Other: Open-label for screened, but not randomized patients with fulminant CDI
This arm exists for patients with fulminant CDI and for randomization to placebo may be considered unethical.
Other: Fecal microbiota transplantion (FMT)
Single donor, fecal microbiota transplantion (FMT) from healthy human donors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of CD-associated diarrhea (CDAD) week 8
Time Frame: 8 weeks following treatment
Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.
8 weeks following treatment
Mortality week 8
Time Frame: 8 weeks following treatment
In the open-label arm for patients who cannot be randomized due to ethical reasons, the primary outcome is mortality.
8 weeks following treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of CD-associated diarrhea (CDAD) week 1
Time Frame: 1 week following treatment
Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.
1 week following treatment
Negative CD toxin-test week 1
Time Frame: 1 week following treatment
Faecal C difficile PCR test
1 week following treatment
Negative CD toxin-test week 8
Time Frame: 8 weeks following treatment
Faecal C difficile PCR test
8 weeks following treatment
Mortality week 8
Time Frame: 8 weeks
Date of death
8 weeks
Colectomy rate week 8
Time Frame: 8 weeks
Date of colectomy
8 weeks
Health-related quality of life
Time Frame: 8 weeks
EDQ5D-5L
8 weeks

Collaborators and Investigators

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

Sponsor

Christian Hvas

Collaborators

Innovation Fund Denmark

Investigators

  • Study Chair: Christian L Hvas, PhD, Aarhus University Hospital

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 (Actual)

June 2, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-254-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data may be obtained in a anonymous form compliant with the General Data Protection Regulation (GDPR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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