NCT07496502

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 18, 2026

Last Update Submit

March 23, 2026

Conditions

Clostridioides Difficile InfectionDrug Resistance, BacterialMultidrug-resistant ColonizationMicrobiotaGastrointestinal Microbiome

Keywords

clostridioides difficile infectionmultidrug-resistance organisms colonizationfecal microbiota transplant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    From capsule administration up to 30 days.

  • Rate of all-cause hospitalization.

    30-day

Study Arms (2)

Microbiota Capsule

EXPERIMENTAL

Oral capsules containing frozen intestinal microbiota derived from healthy donors

Biological: Microbiota capsule

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Microbiota capsuleBIOLOGICAL

Oral capsules containing frozen intestinal microbiota derived from healthy donors.

Microbiota Capsule
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Microbiota

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Microbiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Director

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 27, 2026

Study Start

March 31, 2022

Primary Completion

June 14, 2022

Study Completion

July 1, 2022

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

ME(1)