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Effect of Oral Microbiota on MDRO Decolonization

NCT07496502 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Clostridioides Difficile Infection
  • Drug Resistance, Bacterial
  • Gastrointestinal Microbiome
  • Multidrug-resistant Colonization
  • Microbiota

Interventions

BIOLOGICAL

Microbiota capsule

Oral capsules containing frozen intestinal microbiota derived from healthy donors.

OTHER

Placebo

Oral capsules identical in appearance, containing microcrystalline cellulose (inactive filler)

Sponsors & Collaborators

  • Consejo Nacional de Humanidades, Ciencias y Tecnologias (CONAHCYT)

    collaborator UNKNOWN

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2022-06-14
Completion
2022-07-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07496502 on ClinicalTrials.gov