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.

Study Overview

• Status: Completed
• Conditions: Microbiota; Gastrointestinal Microbiome; Clostridioides Difficile Infection; Multidrug-resistant Colonization; Drug Resistance, Bacterial
• Intervention / Treatment: Biological: Microbiota capsule; Other: Placebo

Detailed Description

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
• Enrollment (Actual): 42
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 14080
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microbiota Capsule; Oral capsules containing frozen intestinal microbiota derived from healthy donors	Biological: Microbiota capsule; Oral capsules containing frozen intestinal microbiota derived from healthy donors.
Placebo Comparator: Placebo; Oral capsules identical in appearance, containing microcrystalline cellulose (inactive filler)	Other: Placebo; Oral capsules identical in appearance, containing microcrystalline cellulose (inactive filler)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 days after the last capsule dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs).	Number of participants with any TEAE, graded by CTCAE v5.0, and specifically gastrointestinal AEs.	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.	30-day

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Collaborators: Consejo Nacional de Humanidades, Ciencias y Tecnologias (CONAHCYT)

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): June 14, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: fecal microbiota transplant; clostridioides difficile infection; multidrug-resistance organisms colonization
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Environment and Public Health; Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Microbiota
• Other Study ID Numbers: SME-2459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Confidentiality issues

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No