Effect of Oral Microbiota on MDRO Decolonization (NCT07496502) | Clinical Trial Compass
CompletedPhase 1/2
Effect of Oral Microbiota on MDRO Decolonization
Mexico42 participantsStarted 2022-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with intestinal decolonization of baseline MDROs or toxigenic C. difficile.
Timeframe: 14 days after the last capsule dose.
Trial details
NCT IDNCT07496502
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran