UnknownNot Applicable

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

Canada, Hungary, Israel196 participantsStarted 2023-11-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consenting adults ≥18 years old with non-fulminant primary CDI. * Both non-severe and severe patients will be included. * Primary CDI (pCDI) will be defined as the patient's first event of CDI in the past 6 months: New-onset diarrhea (≥3 unformed bowel movements (UBM) per day for more than 24 hours) and laboratory detection of toxigenic C. difficile in feces. * A positive CD stool sample will be defined per study center according to international guidelines, with an obligatory positive toxin test to assure the presence of an active toxigenic CD strain. Exclusion Criteria: * Patients who cannot provide informed consent and do not have a legal guardian; * History of CDI 6 months prior to screening * Known presence of other stool pathogens known to cause diarrhea; * Patients who cannot swallow; * Background diagnosis of inflammatory bowel disease, irritable bowel syndrome (IBS), or any other chronic diarrheal disorder; * Active gastrointestinal graft versus host disease (GVHD); * Neutropenia \<500/ml3; * Food allergy leading to anaphylaxis; * Prior total colectomy or the presence of a small intestinal stoma; * Perforated intestine or intestinal fistula or major abdominal surgery in the last 30 days; * Fulminant or life-threatening CDI defined as the occurrence of ileus, septic shock or toxic megacolon. Signs of fulminant disease are: white blood cell count \>30,000 cells/mL; temperature \>40°C; evidence of hypotension \[systolic blood pressure \<90 mmHg\…

What they're measuring

CDI recurrence

Timeframe: 8 weeks

Trial details

NCT IDNCT05709184

SponsorRambam Health Care Campus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11

Contact for this trial

Milena Pitashny, MD

972-4-7771108 m_pitashny@rmc.gov.il