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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Virome Transplantation | Experimental | Treatment with Fecal Virome Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin) |
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| Fecal Microbiota Transplantation | Active Comparator | Treatment with Fecal Microbiota Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Virome Transplantation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical resolution (≤ 3 bowel movements) or diarrhoea with a negative stool sample for C. diffiicile) | Number of patients in each group (FMT and FVT) with clinical resolution | 8 weeks following treatment |
| Participation | Among patients eligible for treatment how many are interesting in participating in study and potentially receiving new virome treatment | 1 week after given information about the study |
| Measure | Description | Time Frame |
|---|---|---|
| Need for rescue Fecal Microbiota Transplantation (FMT) | Number of patients with diarrhoea and stool sample positive for C. diffiicile needing rescue-FMT | Up til eight weeks following treatment |
| Long term recurrence of C. difficile infection |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome changes | Microbiome changes in fecal virome and bacteriome following FMT and FVT treatment | Through samples prior to treatment, one and eight weeks following treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederik Cold, MD, PhD | Contact | 21157167 | frederik.cold@regionh.dk | |
| Morten Helms, MD, PhD | Contact | morten.helms@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Frederik Cold, MD, PhD | Copenhagen University Hospital, Hvidovre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital Hvidovre | Hvidovre | 2650 | Denmark |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Randomised controlled trial comparing study treatment (Fecal Virome Transplantation) to standard treatment (Fecal Microbiota Transplantation)
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Fecal Virome Transplantation and Fecal Microbiota Transplantation capsules will look exactly the same.
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| Fecal microbiota Transplantation | Other | Donor fecal material is mixed with cryoprotectant and NaCl. Following processing the material transfered to capsules and is stored at -80c prior to use. |
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Number of patients registered with recurrence of C. difficile infection (through a positive stool sample) in the first year following treatment
| Up to one year following treatment |
| Side effects | Registered side effects in the first 8 weeks following treatment | Up to eight weeks following treatment |