Clostridium Difficile InfectionsVISIONNCT06398379
Virus as Treatment of C. Difficile Infection (VISION)
A study testing Fecal Virome Transplantation and Fecal microbiota Transplantation in people with Clostridium Difficile Infections, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infections
- What is being tested?
- Fecal Virome Transplantation and Fecal microbiota Transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent C. difficile infection (first or second recurrence)
- Understand danish
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Morten Helms, MD, PhD contact
About this study
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)
Read the 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
- Being tested
- Fecal Virome Transplantation, Fecal microbiota Transplantation
- Keywords
- Fecal Virome Transplantation, Fecal Microbiota Transplantation
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Virome TransplantationOther
Also called Sterile fecal filtrate
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 TransplantationOther
Also called FMT
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 group | Role | What they receive |
|---|---|---|
| Fecal Virome Transplantation | Experimental | Treatment with Fecal Virome Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin) Receives: Other: Fecal Virome Transplantation |
| Fecal Microbiota Transplantation | Active comparator | Treatment with Fecal Microbiota Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin) Receives: Other: Fecal microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks following treatment
Participation
Among patients eligible for treatment how many are interesting in participating in study and potentially receiving new virome treatment
Measured: 1 week after given information about the study
Secondary outcomes (3)
Need for rescue Fecal Microbiota Transplantation (FMT)
Number of patients with diarrhoea and stool sample positive for C. diffiicile needing rescue-FMT
Measured: Up til eight weeks following treatment
Long term recurrence of C. difficile infection
Number of patients registered with recurrence of C. difficile infection (through a positive stool sample) in the first year following treatment
Measured: Up to one year following treatment
Side effects
Registered side effects in the first 8 weeks following treatment
Measured: Up to eight weeks following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial comparing study treatment (Fecal Virome Transplantation) to standard treatment (Fecal Microbiota Transplantation)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Frederik Cold, Copenhagen University Hospital, Hvidovre
- Investigators
- Frederik Cold, MD, PhD, Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398379
- Sponsor's protocol ID
- H-22069168
- Acronym
- VISION
- Status last verified
- Apr 2024
- First submitted
- 21 Mar 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virus as Treatment of C. Difficile Infection (VISION)
- ClinicalTrials.gov ID
- NCT06398379
- Acronym / sponsor ID
- VISION / H-22069168
- Conditions
- Clostridium Difficile Infections
- Keywords
- Fecal Virome Transplantation, Fecal Microbiota Transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial comparing study treatment (Fecal Virome Transplantation) to standard treatment (Fecal Microbiota Transplantation)
| Arm | Type | Receives |
|---|---|---|
| Fecal Virome Transplantation | Experimental | Other: Fecal Virome TransplantationTreatment with Fecal Virome Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin) |
| Fecal Microbiota Transplantation | Active comparator | Other: Fecal microbiota TransplantationTreatment with Fecal Microbiota Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recurrent C. difficile infection (first or second recurrence)
- Understand danish
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Virome TransplantationAlso: Sterile fecal filtrateThe 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 Virome Transplantation |
| Fecal microbiota TransplantationAlso: FMTDonor fecal material is mixed with cryoprotectant and NaCl. Following processing the material transfered to capsules and is stored at -80c prior to use. | Other | Fecal Microbiota Transplantation |
Primary outcome
Clinical resolution (≤ 3 bowel movements) or diarrhoea with a negative stool sample for C. diffiicile)
Time frame: 8 weeks following treatment
Number of patients in each group (FMT and FVT) with clinical resolution
Participation
Time frame: 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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
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C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Morten Helms, MD, PhD contact
Frederik Cold, MD, PhD principal investigator
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Virome Transplantation and Fecal microbiota Transplantation in people with Clostridium Difficile Infections, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederik Cold, MD, PhD (21157167, frederik.cold@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical resolution (≤ 3 bowel movements) or diarrhoea with a negative stool sample for C. diffiicile) (time frame: 8 weeks following treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.