Lyophilized Fecal Microbiome Transfer Versus Vancomycin Monotherapy for Primary Clostridioides Difficile Infection in Adults (DONATE)

• Status: Not yet recruiting
• Trial end date: 2025-02-01

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.

• Phase: N/A

Details

• Lead Sponsor: Rambam Health Care Campus
• Collaborators: European Institute of Oncology; Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Imperial College London; Lithuanian University of Health Sciences; University of Alberta; University of Debrecen
• Treatments: Vancomycin