Virus as Treatment of C. Difficile Infection (VISION)

NCT06398379 | Not Yet Recruiting

• 1 other identifier: H-22069168
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Clostridium Difficile Infections

Keywords

Fecal Virome Transplantation; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (2)

• Clinical resolution (≤ 3 bowel movements) or diarrhoea with a negative stool sample for C. diffiicile)

  Number of patients in each group (FMT and FVT) with clinical resolution

  8 weeks following treatment

• Participation

  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 Outcomes (3)

• Need for rescue Fecal Microbiota Transplantation (FMT)

  Up til eight weeks following treatment

• Long term recurrence of C. difficile infection

  Up to one year following treatment

• Side effects

  Up to eight weeks following treatment

Other Outcomes (1)

• Microbiome changes

  Through samples prior to treatment, one and eight weeks following treatment

Study Arms (2)

Fecal Virome Transplantation

EXPERIMENTAL

Treatment with Fecal Virome Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin)

Other: Fecal Virome Transplantation

Fecal Microbiota Transplantation

ACTIVE COMPARATOR

Treatment with Fecal Microbiota Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin)

Other: Fecal microbiota Transplantation

Interventions

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.

Also known as: Sterile fecal filtrate

Fecal Virome Transplantation

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.

Also known as: FMT

Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Serious food allergy (anaphylaxis)
• Inability to ingest capsules
• Short bowel syndrome
• Pregnancy or planning of pregnancy
• Stoma
• Other condition where FMT is considered contraindicated

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• University of Copenhagen: collaborator

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Frederik Cold, MD, PhD

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederik Cold, MD, PhD

CONTACT

21157167; frederik.cold@regionh.dk

Morten Helms, MD, PhD

CONTACT

morten.helms@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Fecal Virome Transplantation and Fecal Microbiota Transplantation capsules will look exactly the same.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Randomised controlled trial comparing study treatment (Fecal Virome Transplantation) to standard treatment (Fecal Microbiota Transplantation)

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: May 3, 2024
• Study Start: May 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)