Trials / Completed
CompletedNCT07496502
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Clostridioides Difficile Infection
- Drug Resistance, Bacterial
- Gastrointestinal Microbiome
- Multidrug-resistant Colonization
- Microbiota
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2022-03-31
- Primary completion
- 2022-06-14
- Completion
- 2022-07-01
- First posted
- 2026-03-27
- Last updated
- 2026-03-27
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT07496502. Inclusion in this directory is not an endorsement.