Virus as Treatment of C. Difficile Infection (VISION) (VISION)

April 30, 2024 updated by: Frederik Cold, Copenhagen University Hospital, Hvidovre

Fecal Virome Transplantation (FVT) has in small studies shown benefit in the treatment of recurrent C. difficile infection.

In the VISION study we will treat patients with recurrent C. difficile infection with FVT capsules and compare the treatment with Fecal Microbiota Transplantation (FMT) capsules. Both will be following af standard treatment of antibiotics (Vancomycin)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In the VISION study we will treat patients with recurrent C. difficile infection (CDI) with FVT capsules and compare the treatment with Fecal Microbiota Transplantation (FMT) capsules. Patients will be randomised to receive either FMT or FTV capsules.

Patients will be followed for one year to investigate the risk of a new recurrence of CDI.

Patients and researchers involved in the treatment of the patients will be blinded to the treatment

Study Type

Interventional

Enrollment (Estimated)

40

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 Contact

Study Contact Backup

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Copenhagen University Hospital Hvidovre

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Recurrent C. difficile infection (first or second recurrence)
  • Understand danish

Exclusion Criteria:

  • Serious food allergy (anaphylaxis)
  • Other pathogenic bacteria/virus in stool sample prior to inclusion
  • Inability to ingest capsules
  • Gastrointestinal perforation in the 180 days prior to inclusion
  • Previous treatment with FMT og rectal bacteriotherapy in the 180 days prior to inclusion
  • Short bowel syndrome
  • Pregnancy or planning of pregnancy
  • Participation in other clinical trial in the 30 days prior to inclusion
  • Stoma
  • Other condition where FMT is considered contraindicated

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fecal Virome Transplantation
Treatment with Fecal Virome Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin)
Other: Fecal Virome Transplantation
The primary steps of the production of fecal virome transplantation capsules is the same as when producing fecal microbiota transplantation capsules. Through an subsequent proces of filtering bacterial parts of the material are removed. The material, now called fecal virome transplanation material, has then been moved to capsules and stored in -80c untill use.
Other Names:
  • Sterile fecal filtrate
Active Comparator: Fecal Microbiota Transplantation
Treatment with Fecal Microbiota Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin)
Other: Fecal microbiota Transplantation
Donor fecal material is mixed with cryoprotectant and NaCl. Following processing the material transfered to capsules and is stored at -80c prior to use.
Other Names:
  • FMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical resolution (≤ 3 bowel movements) or diarrhoea with a negative stool sample for C. diffiicile)
Time Frame: 8 weeks following treatment
Number of patients in each group (FMT and FVT) with clinical resolution
8 weeks following treatment
Participation
Time Frame: 1 week after given information about the study
Among patients eligible for treatment how many are interesting in participating in study and potentially receiving new virome treatment
1 week after given information about the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for rescue Fecal Microbiota Transplantation (FMT)
Time Frame: Up til eight weeks following treatment
Number of patients with diarrhoea and stool sample positive for C. diffiicile needing rescue-FMT
Up til eight weeks following treatment
Long term recurrence of C. difficile infection
Time Frame: Up to one year following treatment
Number of patients registered with recurrence of C. difficile infection (through a positive stool sample) in the first year following treatment
Up to one year following treatment
Side effects
Time Frame: Up to eight weeks following treatment
Registered side effects in the first 8 weeks following treatment
Up to eight weeks following treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome changes
Time Frame: Through samples prior to treatment, one and eight weeks following treatment
Microbiome changes in fecal virome and bacteriome following FMT and FVT treatment
Through samples prior to treatment, one and eight weeks following treatment

Collaborators and Investigators

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

Sponsor

Copenhagen University Hospital, Hvidovre

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: Frederik Cold, MD, PhD, Copenhagen University Hospital, Hvidovre

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 (Estimated)

May 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-22069168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Clostridium Difficile Infections

Clinical Trials on Fecal Virome Transplantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe