Clostridium Difficile Infections
Conditions
Keywords
Fecal Virome Transplantation, Fecal Microbiota Transplantation
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
Interventions
OTHERFecal 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.
OTHERFecal 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.
Sponsors
University of Copenhagen
Copenhagen University Hospital, Hvidovre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Fecal Virome Transplantation and Fecal Microbiota Transplantation capsules will look exactly the same.
Intervention model description
Randomised controlled trial comparing study treatment (Fecal Virome Transplantation) to standard treatment (Fecal Microbiota Transplantation)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for rescue Fecal Microbiota Transplantation (FMT) | Up til eight weeks following treatment | Number of patients with diarrhoea and stool sample positive for C. diffiicile needing rescue-FMT |
| Long term recurrence of C. difficile infection | Up to one year following treatment | Number of patients registered with recurrence of C. difficile infection (through a positive stool sample) in the first year following treatment |
| Side effects | Up to eight weeks following treatment | Registered side effects in the first 8 weeks following treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microbiome changes | Through samples prior to treatment, one and eight weeks following treatment | Microbiome changes in fecal virome and bacteriome following FMT and FVT treatment |
Countries
Denmark
Contacts
Primary ContactFrederik Cold, MD, PhD
Backup ContactMorten Helms, MD, PhD
Outcome results
None listed