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Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection (EarlyFMT)

Primary Purpose

Clostridium Difficile Infection, Clostridioides Difficile Infection

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fecal microbiota transplantion (FMT)
Placebo
Sponsored by
Christian Hvas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring Fecal microbiota tranplantation, FMT, CDI

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Vancomycin 125 x 4 for 10 days + 2 Fecal Microbota Transplantation

Vancomycin 125 x 4 for 10 days + 2 Placebo

Open-label for screened, but not randomized patients with fulminant CDI

Arm Description

Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, FMT.

Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, placebo.

This arm exists for patients with fulminant CDI and for randomization to placebo may be considered unethical.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 10, 2021
Last Updated
June 7, 2022
Sponsor
Christian Hvas
Collaborators
Innovation Fund Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04885946
Brief Title
Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection
Acronym
EarlyFMT
Official Title
Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christian Hvas
Collaborators
Innovation Fund Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection, Clostridioides Difficile Infection
Keywords
Fecal microbiota tranplantation, FMT, CDI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients are randomized to either vancomycin + 2 FMT or 2 placebo. An open-label arm exists for patients with fulminant CDI.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin 125 x 4 for 10 days + 2 Fecal Microbota Transplantation
Arm Type
Experimental
Arm Description
Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, FMT.
Arm Title
Vancomycin 125 x 4 for 10 days + 2 Placebo
Arm Type
Placebo Comparator
Arm Description
Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, placebo.
Arm Title
Open-label for screened, but not randomized patients with fulminant CDI
Arm Type
Other
Arm Description
This arm exists for patients with fulminant CDI and for randomization to placebo may be considered unethical.
Intervention Type
Other
Intervention Name(s)
Fecal microbiota transplantion (FMT)
Intervention Description
Single donor, fecal microbiota transplantion (FMT) from healthy human donors.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Food coloring, water, glycerol
Primary Outcome Measure Information:
Title
Resolution of CD-associated diarrhea (CDAD) week 8
Description
Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.
Time Frame
8 weeks following treatment
Title
Mortality week 8
Description
In the open-label arm for patients who cannot be randomized due to ethical reasons, the primary outcome is mortality.
Time Frame
8 weeks following treatment
Secondary Outcome Measure Information:
Title
Resolution of CD-associated diarrhea (CDAD) week 1
Description
Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test.
Time Frame
1 week following treatment
Title
Negative CD toxin-test week 1
Description
Faecal C difficile PCR test
Time Frame
1 week following treatment
Title
Negative CD toxin-test week 8
Description
Faecal C difficile PCR test
Time Frame
8 weeks following treatment
Title
Mortality week 8
Description
Date of death
Time Frame
8 weeks
Title
Colectomy rate week 8
Description
Date of colectomy
Time Frame
8 weeks
Title
Health-related quality of life
Description
EDQ5D-5L
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian L Hvas, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data may be obtained in a anonymous form compliant with the General Data Protection Regulation (GDPR)
Citations:
PubMed Identifier
36152636
Citation
Baunwall SMD, Andreasen SE, Hansen MM, Kelsen J, Hoyer KL, Ragard N, Eriksen LL, Stoy S, Rubak T, Damsgaard EMS, Mikkelsen S, Erikstrup C, Dahlerup JF, Hvas CL. Faecal microbiota transplantation for first or second Clostridioides difficile infection (EarlyFMT): a randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Dec;7(12):1083-1091. doi: 10.1016/S2468-1253(22)00276-X. Epub 2022 Sep 22.
Results Reference
derived

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Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection

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