Effect of Oral Microbiota on MDRO Decolonization

Effect of Oral Intestinal Microbiota Administration on the Decolonization of Multidrug-Resistant Organisms in Patients Undergoing Prolonged Antibiotic Therapy: A Randomized, Placebo-Controlled Trial

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.

Patients scheduled for ≥7 days of systemic antibiotics were eligible. Exclusion criteria included severe immunodeficiency, pregnancy, or short life expectancy. Participants received frozen, encapsulated intestinal microbiota from screened donors or identical placebo capsules orally during hospitalization. Stool samples were collected at baseline and day 14 for culture and PCR for MDROs (ESBL, CRE, VRE) and toxigenic C. difficile. Patients were followed for 30 days for clinical outcomes. The study aimed to determine whether administering microbiota could safely enhance gut decolonization and affect subsequent infections.

Inclusion Criteria:

• Adult patients (≥18 years old).
• Hospitalized and scheduled to receive systemic antibiotic therapy for a minimum expected duration of 7 days.
• Able to provide written informed consent.

Exclusion Criteria:

• Severe immunodeficiency (e.g., absolute neutrophil count <500/µL, solid organ transplant within 6 months, active hematologic malignancy on chemotherapy).
• Pregnancy or breastfeeding.
• Life expectancy < 3 months.
• History of total colectomy or ileostomy.
• Known hypersensitivity or allergy to any component of the study capsules.
• Inability to swallow capsules.