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Virus as Treatment of C. Difficile Infection (VISION)

ConditionClostridium Difficile Infections
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCopenhagen University Hospital, Hvidovre

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Recurrent C. difficile infection (first or second recurrence)

Understand danish

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fecal Virome Transplantation

    Other intervention

    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

    Other intervention

    Donor fecal material is mixed with cryoprotectant and NaCl. Following processing the material transfered to capsules and is stored at -80c prior to use.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Fecal Virome TransplantationExperimental treatment 1 intervention
Group B: Fecal Microbiota TransplantationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
8 weeks following treatment
2

Participation

Among patients eligible for treatment how many are interesting in participating in study and potentially receiving new virome treatment

Time frame
1 week after given information about the study

Secondary outcomes

1

Need for rescue Fecal Microbiota Transplantation (FMT)

Number of patients with diarrhoea and stool sample positive for C. diffiicile needing rescue-FMT

Time frame
Up til eight weeks following treatment
2

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

Time frame
Up to one year following treatment
3

Side effects

Registered side effects in the first 8 weeks following treatment

Time frame
Up to eight weeks following treatment

Other outcomes

1

Microbiome changes

Microbiome changes in fecal virome and bacteriome following FMT and FVT treatment

Time frame
Through samples prior to treatment, one and eight weeks following treatment

Sponsors and contacts

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Copenhagen University Hospital, Hvidovre

Lead sponsor

University of Copenhagen

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: