Virus as Treatment of C. Difficile Infection (VISION)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fecal Virome Transplantation, Fecal microbiota Transplantation.
- Who it may be relevant to
- Registry conditions: Clostridium Difficile Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- 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.
Primary outcome measures
- Clinical resolution (≤ 3 bowel movements) or diarrhoea with a negative stool sample for C. diffiicile) [Time frame: 8 weeks following treatment]
- Participation [Time frame: 1 week after given information about the study]
Secondary outcome measures (3)
- Need for rescue Fecal Microbiota Transplantation (FMT) [Time frame: Up til eight weeks following treatment]
- Long term recurrence of C. difficile infection [Time frame: Up to one year following treatment]
- Side effects [Time frame: Up to eight weeks following 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Copenhagen University Hospital Hvidovre — Hvidovre
Identifiers
NCT: NCT06398379 · H-22069168