NCT06398379

Virus as Treatment of C. Difficile Infection (VISION)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Copenhagen University Hospital, Hvidovre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Clostridium Difficile Infections

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-01-01
• Completion: 2026-12-31
• First posted: 2024-05-03
• Last updated: 2024-05-03

Locations

1 site across 1 country: Denmark