RecruitingNot ApplicableNCT05709184

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

Lyophilized Fecal Microbiome Transfer for Primary Clostridioides Difficile Infection (DONATE Study): a Multicenter Randomized Controlled Trial

Sponsor

Rambam Health Care Campus

Enrollment

196 participants

Start Date

Nov 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This multinational trial tests whether giving lyophilized (freeze-dried, oral capsule) fecal microbiome transfer (Lyo-FMT) — capsules containing bacteria from healthy donor stool — after a short course of antibiotics prevents the recurrence of Clostridioides difficile infection (CDI) more effectively than a longer course of antibiotics alone. CDI is a serious intestinal infection that frequently recurs and is increasingly common in both hospitals and the community. Adults aged 18 and older with their first CDI episode in the past 6 months, confirmed by a positive toxin stool test, who are not critically ill may be eligible; people with inflammatory bowel disease, prior total colectomy, neutropenia, or certain other conditions are excluded. Participation involves taking oral vancomycin (either 5 days followed by FMT capsules, or 10 days alone), providing stool samples, and attending two follow-up visits over 8 weeks. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTLyophilized 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.

DRUGVancomycin

Ten days of oral vancomycin 125 mg four times daily