Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence

NCT05266807 | Recruiting Phase 3

• 1 other identifier: FENDER
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 7

Brief Summary

The clinical trial aims to evaluate the efficacy of fecal microbiota transplantation (FMT) after standard of care treatment (either vancomycin or fidaxomicin) vs the pragmatic use of standard of care treatment (either vancomycin or fidaxomicin) in severe and non-severe first episode and first recurrence of Clostridioides difficile infection (CDI). Experimental arm: antibiotic treatment (vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days) followed by FMT by oral capsules (one FMT, i.e. 20 FMT capsules given on 2 consecutive days, and followed by a 2nd FMT in severe CDI). Control Arm: vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days.

Conditions

Clostridioides Difficile Infection

Keywords

Clostridioides difficile; Clostridium difficile; Fecal Microbiota Transplantation; Vancomycin; Fidaxomicin

Outcome Measures

Primary Outcomes (1)

• Sustained clinical cure rate

  Absence of CDI recurrence through 8 weeks after study treatment completion

  8 weeks after study treatment completion

Secondary Outcomes (7)

• Treatment failure

  Before 4 weeks and at 5-8 weeks after study treatment completion

• CDI new episodes

  between 8 weeks and 12 months after study treatment completion

• Long-term clinical cure

  6 and 12 months after study treatment completion

• Recurrence-free survival rate

  12 months after study treatment completion

• Overall survival

  12 months after study treatment completion

Study Arms (2)

SoC + oral Fecal Microbiota Transplantation

EXPERIMENTAL

Antibiotic (vancomycin 125 mg 4 times daily or fidaxomicin 200 mg 2 times daily, as initially prescribed per SoC) for 10 days, followed 12h to 4 days later by one oral FMT (20 capsules administered at D1 and 20 capsules at D2), and a second oral FMT if CDI is severe.

Drug: oral capsulized Fecal Microbiota Transplantation; Drug: Vancomycin or Fidaxomicin

SoC

ACTIVE COMPARATOR

Antibiotic (vancomycin 125 mg 4 times daily or fidaxomicin 200 mg 2 times daily, as initially prescribed per SoC) for 10 days.

Drug: Vancomycin or Fidaxomicin

Interventions

oral capsulized Fecal Microbiota Transplantation DRUG

FMT will be administered per os in the form of capsules containing faeces from a healthy donor. Capsules are manufactured at the CHUV pharmacy (University Hospital of Lausanne, Switzerland)

SoC + oral Fecal Microbiota Transplantation

Vancomycin or Fidaxomicin DRUG

Vancomycin or Fidaxomicin per os as initially prescribed per SoC

SoC; SoC + oral Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years old) at the time of informed consent
• Informed consent signature
• Medical record documentation of CDI defined as:
• a. A first CDI episode associated with risks factors for recurrence, defined as: i. No CDI episode within the last 8 weeks ii. Current combination of CDI signs and symptoms, confirmed by medical record documentation of microbiological evidence of C. difficile toxin and C. difficile in stools shown by a CDI PCR positive test with Ct \< 25 or a toxin A/B EIA positive test and without reasonable evidence of another cause of diarrhea, iii. Presenting at least one of the following risks factors for CDI recurrence:
• age \>65 years-old,
• hospitalization within the last 3 months,
• use of proton pump inhibitors (PPI) within the last 3 months,
• Charlson comorbidity index (CCI) \>2,
• living in long term facility,
• healthcare- associated CDI (see definition in section 7),
• severe CDI episode (see definitions in section 6.1.2),
• immunocompromised patient (except severely immunocompromised according to definitions in section 7.1),
• history of prior CDI episode(s) (more than 8 weeks ago). OR b. A first CDI recurrence, defined as: i. Previous episode of treated and cured CDI within the last 8 weeks confirmed by medical record documentation of a clinical picture of CDI combined with a positive microbiological CDI test performed according to CDI diagnosis ESCMID guidelines ii. Current combination of CDI signs and symptoms, confirmed by medical record documentation of microbiological evidence of C. difficile toxin and C. difficile in stools shown by a CDI PCR positive test with Ct \< 25 or a toxin A/B EIA positive test , and without reasonable evidence of another cause of diarrhea..
• No multiple episodes (no more than 2 CDI episodes) within 3 last months.
• Already taking since less than 10 days or will start a course of antibiotics (vancomycin or fidaxomicin) to control recurrent CDI symptoms at the time of screening.

You may not qualify if:

• Severe-complicated CDI if at least one of the following signs or symptoms are:
• ongoing at time of screening and related to CDI: hypotension, septic shock, elevated serum lactate, ileus,
• or were present at any time of the CDI episode and related to CDI: toxic megacolon, bowel perforation, or any fulminant course of disease (i.e. rapid deterioration of the patient.
• Prior FMT within 6 months of randomization,
• Prior colectomy, colostomy, ileostomy, or gastrectomy
• Metronidazole already given for the treatment of the current CDI for more than 3 days,
• Need for continued non-anti-CDI systemic antibiotics (should be stopped at randomization at the latest), except prophylactic doses of trimethoprim/sulfamethoxazole,
• Anticipated indication for antibiotics treatment (for a non-CDI reason) in the next 8 weeks except prophylactic doses of trimethoprim/sulfamethoxazole
• Other causes of chronic or acute diarrhea beyond CDI (chronic diarrhea is defined as loose/watery stools, which occur three or more times within 24 hours and last for 4 or more weeks)
• Inflammatory bowel disease,
• Patients with swallowing disorders, Zenker's diverticulum, gastroparesis, or prior small bowel obstruction,
• Known hypersensitivity to vancomycin or fidaxomicin,
• Pregnant/lactating women,
• Estimated patient's life expectancy of less than 10 weeks,
• Inability to follow protocol study procedures,

Sponsors & Collaborators

• Benoit Guery: lead

Study Sites (7)

Universitätsspital

Basel, Basel, 4031, Switzerland

RECRUITING

Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

HFR Fribourg - Hôpital cantonal

Fribourg, Canton of Fribourg, 1708, Switzerland

RECRUITING

Kantonsspital St Gallen, HOCH

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Universitätsspital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Institut central des hôpitaux

Sion, Valais, 1950, Switzerland

RECRUITING

MeSH Terms

Conditions

Clostridium Infections

Interventions

Vancomycin; Fidaxomicin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Benoit Guery

  CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benoit Guery, MD

CONTACT

+41213141643; benoit.guery@chuv.ch

Project Manager

CONTACT

+41795564371; crc.fender@chuv.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head physician

Model Details: Randomized, Controlled, Open-label, Multicenter

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 4, 2022
• Study Start: March 15, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (7)