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.
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.
Study 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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Clinical resolution (≤ 3 bowel movements) or diarrhoea with a negative stool sample for C. diffiicile) — 8 weeks following treatment Number of patients in each group (FMT and FVT) with clinical resolution
Participation — 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
Trial sites (1)
Facility
City
Region
Status
Copenhagen University Hospital Hvidovre
Hvidovre
Denmark
More Copenhagen University Hospital, Hvidovre trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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