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

ConditionClostridioides Difficile Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenoit Guery

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥18 years old) at the time of informed consent

Informed consent signature

age >65 years-old,

hospitalization within the last 3 months,

Disqualifiers

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 total colectomy, colostomy, ileostomy, or gastrectomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

  • Vancomycin or Fidaxomicin

    Drug

    Vancomycin or Fidaxomicin per os as initially prescribed per SoC

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: SoC + oral Fecal Microbiota TransplantationExperimental treatment 2 interventions
Group B: SoCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sustained clinical cure rate

Absence of CDI recurrence through 8 weeks after study treatment completion

Time frame
8 weeks after study treatment completion

Secondary outcomes

1

Treatment failure

Early and late CDI recurrence rate

Time frame
Before 4 weeks and at 5-8 weeks after study treatment completion
2

CDI new episodes

CDI new episodes occurence rate

Time frame
between 8 weeks and 12 months after study treatment completion
3

Long-term clinical cure

Long-term clinical cure rate

Time frame
6 and 12 months after study treatment completion
4

Recurrence-free survival rate

Time from study intervention until CDI recurrence

Time frame
12 months after study treatment completion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benoit Guery

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Sponsor institution

Source ClinicalTrials.gov
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