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

Launched by RAMBAM HEALTH CARE CAMPUS · Jan 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for Clostridioides difficile infection (CDI), a type of infection that can cause severe diarrhea. Researchers want to find out if a treatment called lyophilized fecal microbiome transfer, which involves taking dried bacteria from healthy donors' stool, is more effective than a standard antibiotic treatment (vancomycin) alone. Participants in the study will either receive vancomycin for ten days or vancomycin followed by the fecal microbiome capsules for five days. The goal is to see if the new treatment helps reduce the number of times the infection comes back.

To be eligible for the trial, participants must be adults over 18 years old who are experiencing their first CDI infection within the last six months. They cannot have had CDI in the previous six months or any other serious gastrointestinal issues. Participants will need to attend follow-up visits and provide stool samples for testing. Throughout the study, researchers will monitor how well the treatments work and any side effects that may occur. Overall, this trial aims to explore a promising new option for treating CDI.

Gender

ALL

Eligibility criteria

• 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 \[systolic blood pressure \<90 mmHg\], peritoneal signs, and significant dehydration;
• • Early fulminant CDI (ICU patients) defined as patients showing progression despite treatment with a sequential organ failure assessment score (SOFA score) ≥ 4 due to CDI (13) at day 2 of treatment (prior to randomization);
• • Patients who receive systemic antibiotics due to other reasons which cannot be stopped until 1 day prior to randomization (day 2 of antibiotic therapy);
• • Patients that were not recruited to the study by day 4 of CDI therapy will be excluded from participation;
• • Patients with \<3 months life expectancy;
• • Inability or unwillingness to comply with the study protocol, including ingesting capsules, and providing blood or stool samples as scheduled;
• • Participation in another interventional study;
• • In the opinion of the investigator, inappropriateness for the trial (eg, patients with known hypersensitivity to vancomycin);
• • Pregnancy and breastfeeding.