Clostridioides Difficile InfectionPhase 1/2NCT07496502
Effect of Oral Microbiota on MDRO Decolonization
A Phase 1/2 study testing Microbiota capsule in people with Clostridioides Difficile Infection and Drug Resistance, Bacterial, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridioides Difficile Infection, Drug Resistance, Bacterial, Gastrointestinal Microbiome
- What is being tested?
- Microbiota capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteMexico
- Study dates
- 31 Mar 2022to 1 Jul 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14080
About this study
Official 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
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.
Read the 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
- Being tested
- Microbiota capsule, Placebo
- Keywords
- clostridioides difficile infection, multidrug-resistance organisms colonization, fecal microbiota transplant
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiota capsuleBiological
Oral capsules containing frozen intestinal microbiota derived from healthy donors.
PlaceboOther
Oral capsules identical in appearance, containing microcrystalline cellulose (inactive filler)
| Study group | Role | What they receive |
|---|---|---|
| Microbiota Capsule | Experimental | Oral capsules containing frozen intestinal microbiota derived from healthy donors Receives: Biological: Microbiota capsule |
| Placebo | Placebo comparator | Oral capsules identical in appearance, containing microcrystalline cellulose (inactive filler) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days after the last capsule dose.
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events (TEAEs).
Number of participants with any TEAE, graded by CTCAE v5.0, and specifically gastrointestinal AEs.
Measured: From capsule administration up to 30 days.
Rate of all-cause hospitalization.
Number of participants requiring hospitalization for any reason after receiving the study intervention.
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start31 Mar 2022
- Primary completion14 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- Consejo Nacional de Humanidades, Ciencias y Tecnologias (CONAHCYT)
- Responsible party
- Principal investigator, Jose Sifuentes Osornio, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496502
- Sponsor's protocol ID
- SME-2459
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Confidentiality issues
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07496502
- Acronym / sponsor ID
- SME-2459
- Conditions
- Clostridioides Difficile Infection, Drug Resistance, Bacterial, Gastrointestinal Microbiome, Multidrug-resistant Colonization, Microbiota
- Keywords
- clostridioides difficile infection, multidrug-resistance organisms colonization, fecal microbiota transplant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- Consejo Nacional de Humanidades, Ciencias y Tecnologias (CONAHCYT)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microbiota Capsule | Experimental | Biological: Microbiota capsuleOral capsules containing frozen intestinal microbiota derived from healthy donors |
| Placebo | Placebo comparator | Other: PlaceboOral capsules identical in appearance, containing microcrystalline cellulose (inactive filler) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiota capsuleOral capsules containing frozen intestinal microbiota derived from healthy donors. | Biological | Microbiota Capsule |
| PlaceboOral capsules identical in appearance, containing microcrystalline cellulose (inactive filler) | Other | Placebo |
Primary outcome
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.
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (TEAEs).
Time frame: From capsule administration up to 30 days.
Rate of all-cause hospitalization.
Time frame: 30-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided. Confidentiality issues
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Microbiota capsule in people with Clostridioides Difficile Infection and Drug Resistance, Bacterial, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with intestinal decolonization of baseline MDROs or toxigenic C. difficile. (time frame: 14 days after the last capsule dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.