## Protocol Section
### Identification Module
**NCT ID:** NCT06398379

**Acronym:** VISION

**Brief Title:** Virus as Treatment of C. Difficile Infection (VISION)

**Official Title:** Virus as Treatment of C. Difficile Infection (VISION)

#### Organization Study ID Info
**ID:** H-22069168
#### Organization
**Class:** OTHER
**Full Name:** Copenhagen University Hospital, Hvidovre
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-03

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-03
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-21
**Study First Submit QC Date:** 2024-04-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Copenhagen

#### Lead Sponsor

**Class:** OTHER

**Name:** Copenhagen University Hospital, Hvidovre

#### Responsible Party

**Investigator Affiliation:** Copenhagen University Hospital, Hvidovre

**Investigator Full Name:** Frederik Cold

**Investigator Title:** MD, PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Clostridium Difficile Infections

**Keywords:**

- Fecal Virome Transplantation

- Fecal Microbiota Transplantation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomised controlled trial comparing study treatment (Fecal Virome Transplantation) to standard treatment (Fecal Microbiota Transplantation)

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** Fecal Virome Transplantation and Fecal Microbiota Transplantation capsules will look exactly the same.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Treatment with Fecal Virome Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin)

**Intervention Names:**

- Other: Fecal Virome Transplantation

**Label:** Fecal Virome Transplantation

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Treatment with Fecal Microbiota Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin)

**Intervention Names:**

- Other: Fecal microbiota Transplantation

**Label:** Fecal Microbiota Transplantation

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Fecal Virome Transplantation

**Description:** 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.

**Name:** Fecal Virome Transplantation

**Other Names:**

- Sterile fecal filtrate

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Fecal Microbiota Transplantation

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

**Name:** Fecal microbiota Transplantation

**Other Names:**

- FMT

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** Microbiome changes in fecal virome and bacteriome following FMT and FVT treatment

**Measure:** Microbiome changes

**Time Frame:** Through samples prior to treatment, one and eight weeks following treatment

#### Primary Outcomes

**Description:** Number of patients in each group (FMT and FVT) with clinical resolution

**Measure:** Clinical resolution (≤ 3 bowel movements) or diarrhoea with a negative stool sample for C. diffiicile)

**Time Frame:** 8 weeks following treatment

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

**Measure:** Participation

**Time Frame:** 1 week after given information about the study

#### Secondary Outcomes

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

**Measure:** Need for rescue Fecal Microbiota Transplantation (FMT)

**Time Frame:** Up til eight weeks following treatment

**Description:** Number of patients registered with recurrence of C. difficile infection (through a positive stool sample) in the first year following treatment

**Measure:** Long term recurrence of C. difficile infection

**Time Frame:** Up to one year following treatment

**Description:** Registered side effects in the first 8 weeks following treatment

**Measure:** Side effects

**Time Frame:** Up to eight weeks following treatment

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** frederik.cold@regionh.dk

**Name:** Frederik Cold, MD, PhD

**Phone:** 21157167

**Role:** CONTACT

**Contact 2:**

**Email:** morten.helms@regionh.dk

**Name:** Morten Helms, MD, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hvidovre

**Country:** Denmark

**Facility:** Copenhagen University Hospital Hvidovre

**Zip:** 2650

#### Overall Officials

**Official 1:**

**Affiliation:** Copenhagen University Hospital, Hvidovre

**Name:** Frederik Cold, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000016908

- Term: Gram-Positive Bacterial Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6247

- Name: Clostridium Infections

- Relevance: HIGH

- As Found: Clostridium Difficile Infection

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M19252

- Name: Gram-Positive Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000003015

- Term: Clostridium Infections

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17388

- Name: Vancomycin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
