drugset / Trial / NCT07496502
Effect of Oral Microbiota on MDRO Decolonization
Phase 1/2
Completed
42 enrolled
National Institute of Medical Sciences and Nutrition Salvador Zubiran
Consejo Nacional de Humanidades, Ciencias y Tecnologias (CONAHCYT) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2022-03-31
- Primary completion
- 2022-06-14
- Completion
- 2022-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Microbiota capsule | Other / unclassified | — | Oral |