Clostridioides Difficile Infection, Drug Resistance, Bacterial, Gastrointestinal Microbiome, Multidrug-resistant Colonization, Microbiota
Conditions
Keywords
clostridioides difficile infection, multidrug-resistance organisms colonization, fecal microbiota transplant
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.
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.
Interventions
BIOLOGICALMicrobiota capsule
Oral capsules containing frozen intestinal microbiota derived from healthy donors.
OTHERPlacebo
Oral capsules identical in appearance, containing microcrystalline cellulose (inactive filler)
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Consejo Nacional de Humanidades, Ciencias y Tecnologias (CONAHCYT)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with intestinal decolonization of baseline MDROs or toxigenic C. difficile. | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs). | From capsule administration up to 30 days. | Number of participants with any TEAE, graded by CTCAE v5.0, and specifically gastrointestinal AEs. |
| Rate of all-cause hospitalization. | 30-day | Number of participants requiring hospitalization for any reason after receiving the study intervention. |
Countries
Mexico
Outcome results
None listed