Effect of Oral Microbiota on MDRO Decolonization

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Clostridioides Difficile Infection Drug Resistance, Bacterial

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of patients with intestinal decolonization of baseline MDROs or toxigenic C. difficile.

Clearance is defined as the absence of the specific baseline MDRO strain(s) or C. difficile toxin B gene in the stool sample collected at Day 14, compared to the baseline sample.

Time frame: 14 days after the last capsule dose.

Secondary Outcomes

Incidence of Treatment-Emergent Adverse Events (TEAEs).

Number of participants with any TEAE, graded by CTCAE v5.0, and specifically gastrointestinal AEs.

Time frame: From capsule administration up to 30 days.

Rate of all-cause hospitalization.

Number of participants requiring hospitalization for any reason after receiving the study intervention.

Time frame: 30-day