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Status:

RECRUITING

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

Lead Sponsor:

Benoit Guery

Conditions:

Clostridioides Difficile Infection

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 ...

Detailed Description

Clostridioides difficile (CDI) is well known as major agent of healthcare-associated diarrhea in adult patients. One of the main challenges is the prevention of recurrence of Clostridioides difficile ...

Eligibility Criteria

Inclusion

  • 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.
  • Willing and able to have FMT by capsule

Exclusion

  • 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,
  • Inability to give informed consent,
  • Any condition or medications that will put the participant at greater risk from FMT according to the investigator,
  • Severely immunocompromised
  • No response to anti-CDI antibiotic treatment after at least 5 days of treatment (i.e. no diminution of the daily number of stools at BSS 6-7 compared to first day of treatment; or worsening of CDI severity parameters)

Key Trial Info

Start Date :

March 15 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 31 2028

Estimated Enrollment :

220 Patients enrolled

Trial Details

Trial ID

NCT05266807

Start Date

March 15 2023

End Date

January 31 2028

Last Update

September 18 2025

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Universitätsspital

Basel, Basel, Switzerland, 4031

2

Inselspital Bern

Bern, Canton of Bern, Switzerland, 3010

3

HFR Fribourg - Hôpital cantonal

Fribourg, Canton of Fribourg, Switzerland, 1708

4

Kantonsspital St Gallen, HOCH

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