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Completed

NCT Number: NCT07496502

Effect of Oral Microbiota on MDRO Decolonization

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.

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Key information

Conditions

Clostridioides Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Drug Resistance, Bacterial Gastrointestinal Microbiome Gram-Positive Bacterial Infections Infections Microbiota Multidrug-resistant Colonization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microbiota capsule

Biological

Oral capsules containing frozen intestinal microbiota derived from healthy donors.

Placebo

Other

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

Primary outcomes

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

    Time frame: 14 days after the last capsule dose.

    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.

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs).

    Time frame: From capsule administration up to 30 days.

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

  2. Rate of all-cause hospitalization.

    Time frame: 30-day

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

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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