Virus as Treatment of C. Difficile Infection (VISION)

Clostridium Difficile Infections Clinical Trial

— VISION  

Official title:

Virus as Treatment of C. Difficile Infection (VISION)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398379
• Other study ID #: H-22069168
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Copenhagen University Hospital, Hvidovre
• Contact: Frederik Cold, MD, PhD
• Phone: 21157167
• Email: frederik.cold[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Both will be following af standard treatment of antibiotics (Vancomycin)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infections
• Clostridium Infections
• Communicable Diseases
• Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Hvidovre	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Secondary	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
Secondary	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	Up to one year following treatment
Secondary	Side effects	Registered side effects in the first 8 weeks following treatment	Up to eight weeks following treatment