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NCT Number: NCT06398379

Virus as Treatment of C. Difficile Infection (VISION)

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)

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Key information

Conditions

Clostridium Difficile Infections Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal Virome Transplantation

Other

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

Fecal microbiota transplantation

Other

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. Side effects

    Time frame: Up to eight weeks following treatment

    Registered side effects in the first 8 weeks following treatment

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Frederik Cold, MD, PhD

CONTACT

[email protected]

21157167

Morten Helms, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Collaborators

  • University of Copenhagen

Registry information

Acronym: VISION

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 3, 2024
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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