Clinical Trial

Effect of Oral Microbiota on MDRO Decolonization

Completed Phase 1/2
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Summary
Randomized, placebo-controlled trial to evaluate the safety and efficacy of oral intestinal microbiota capsules for decolonizing multidrug-resistant organisms (MDROs) and Clostridioides difficile in patients requiring prolonged antibiotic therapy. The primary outcome was clearance of pre-existing MDROs or C. difficile from stool 14 days post-intervention. Secondary outcomes included adverse events, hospitalization rates, and need for additional antibiotics during 30-day follow-up.
Trial Details
NCT Number NCT07496502
Lead Sponsor Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators: Consejo Nacional de Humanidades, Ciencias y Tecnologias (CONAHCYT)
Conditions Clostridioides Difficile Infection, Drug Resistance, Bacterial, Gastrointestinal Microbiome, Multidrug-resistant Colonization, Microbiota
Enrollment 42 participants
Start Date 2022-03-31
Primary Completion 2022-06-14 (estimated)
Study Completion 2022-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-27