Virus as Treatment of C. Difficile Infection (VISION)

Copenhagen University Hospital, Hvidovre

Status: Not yet enrolling

Conditions: Clostridium Difficile Infections

Treatments: Other: Fecal Virome Transplantation; Other: Fecal microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06398379

H-22069168

Details and patient eligibility

About

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)

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Fecal Virome Transplantation

Experimental group

Description:

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

Treatment:

Other: Fecal Virome Transplantation

Fecal Microbiota Transplantation

Active Comparator group

Description:

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

Treatment:

Other: Fecal microbiota Transplantation