Clinical trial NCT06398379: Virus as Treatment of C. Difficile Infection (VISION)
Official title: Virus as Treatment of C. Difficile Infection (VISION)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clostridium Difficile Infections
Keywords: Fecal Virome Transplantation
Fecal Microbiota Transplantation
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2024-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial comparing study treatment (Fecal Virome Transplantation) to standard treatment (Fecal Microbiota Transplantation)
Primary purpose: TREATMENT

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)

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

Eligibility criteria: 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

Primary outcomes:
measure: Clinical resolution (≤ 3 bowel movements) or diarrhoea with a negative stool sample for C. diffiicile)
timeFrame: 8 weeks following treatment
measure: Participation
timeFrame: 1 week after given information about the study
Secondary outcomes:
measure: Need for rescue Fecal Microbiota Transplantation (FMT)
timeFrame: Up til eight weeks following treatment
measure: Long term recurrence of C. difficile infection
timeFrame: Up to one year following treatment
measure: Side effects
timeFrame: Up to eight weeks following treatment
Other outcomes:
measure: Microbiome changes
timeFrame: Through samples prior to treatment, one and eight weeks following treatment
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital Hvidovre
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: Frederik Cold, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: