Lyophilized Fecal Microbiome Transfer vs. Vancomycin Monotherapy for Primary Clostridioides Difficile Infection

Summary

The goal of this clinical trial is to test whether lyophilized fecal microbime transfer - a dried extract of bacteria from the stool of healthy donors - is better than antibiotic therapy only for treating primary clostridioides difficile infection (CDI) in adult participants.

The main question it aims to answer is whether lyophilized fecal microbiome transfer lowers the number of episodes of CDI compared to antibiotic therapy.

Participants will be assigned to one of two groups:

* In the intervention group participants will be given vancomycin by mouth for five days followed by 5 days of capsules of lyophilized fecal microbiome to swallow, up until day 10.
* In the control group participants will be given vancomycin by mouth for ten days.
* All participants will be asked to arrive for two follow-up visits and to fill out questionnaires. In addition, all participants will be asked to give stool samples before antibiotic therapy and on the two follow-up visits.

Researchers will compare the intervention group and the control group to see if there is a difference in symptoms degree after ten days and in recurrence of the infection after two months. They will also compare side effects, the total use of antibiotics and the change in the composition of bacteria in the stool, namely the presence of bacteria that are resistant to many drugs.

Conditions

• Clostridioides Difficile Infection

Interventions

COMBINATION_PRODUCT

Lyophilized fecal microbiome transfer

Five days of vancomycin followed by five days of lyophilized fecal microbiome transfer, administered in a loading dose of 15 capsules, and a daily maintenance dose of 10 capsules.

DRUG

Vancomycin

Ten days of oral vancomycin 125 mg four times daily

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• European Institute of Oncology

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• University of Debrecen

  collaborator OTHER

• Lithuanian University of Health Sciences

  collaborator OTHER

• Rambam Health Care Campus

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-15

Primary Completion

2025-11-30

Completion

2026-03-31

Countries

• Canada
• Hungary
• Israel
• Italy
• Lithuania
• United Kingdom

Study Locations