Enterobacteriaceae InfectionsNCT07707869
Study of Probiotic Adjunctive Therapy for Decolonization of Carbapenem-Resistant Enterobacterales
A study testing Probiotic Preparation and Conventional Antibiotic in people with Enterobacteriaceae Infections and Carrier State, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
To evaluate the efficacy of probiotic preparations as adjunctive therapy for the decolonization of intestinal carbapenem-resistant organisms (CRO), in comparison with conventional antibiotic therapy alone, with the primary endpoints including: (1) the clearance rate of intestinal CRO, defined as negative culture for… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Enterobacteriaceae Infections, Carrier State
- What is being tested?
- Probiotic Preparation and Conventional Antibiotic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Laboratory-confirmed intestinal colonization of carbapenem-resistant Enterobacterales, primarily carbapenem-resistant Escherichia coli and Salmonella spp., based on stool culture or rectal swab.
- Hepatic and renal function within normal limits or with only mild abnormalities, as determined by the investigator, to permit safe administration of the intended treatment.
- Able and willing to receive the assigned treatment regimen (either standard antibiotic therapy alone or with adjunctive probiotics) as per the study protocol.
Who cannot join
- Known hypersensitivity or allergy to any excipient of the probiotic preparation, including but not limited to milk/whey, lactose, soy, corn starch, maltodextrin, sweeteners, or flavors.
- Pregnancy or breastfeeding at the time of screening or during the study period.
- Severe chronic organ dysfunction, including but not limited to cardiac, hepatic, or renal failure, that in the investigator's opinion would compromise patient safety or study outcomes.
- Immunocompromised status, including but not limited to active chemotherapy, radiotherapy, solid organ transplantation, hematopoietic stem cell transplantation, or long-term use of immunosuppressive agents.
- Use of concomitant medications that may have serious interactions with the probiotic preparation or that could confound the assessment of the primary outcome, as judged by the investigator.
- Current participation in another interventional clinical trial, or participation within 30 days prior to screening, or any previous enrollment in a trial that could interfere with the objectives of this study.
- Inability or unwillingness to comply with the study visit schedule or other protocol requirements.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Clinical Laboratory, 2nd Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Clinical Laboratory, 2nd Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
About this study
Official title: An Study on the Efficacy of Probiotic Preparations as Adjunctive Therapy for Decolonization of Carbapenem-Resistant Enterobacterales
To evaluate the efficacy of probiotic preparations as adjunctive therapy for the decolonization of intestinal carbapenem-resistant organisms (CRO), in comparison with conventional antibiotic therapy alone, with the primary endpoints including: (1) the clearance rate of intestinal CRO, defined as negative culture for carbapenem-resistant organisms, and (2) the safety assessment of the treatment, through the documentation of adverse events and potential side effects.
- Conditions
- Enterobacteriaceae Infections, Carrier State
- Being tested
- Probiotic Preparation, Conventional Antibiotic
- Keywords
- Probiotics, Enterobacterales infection
- Medical subject headings
- Enterobacteriaceae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic PreparationDietary supplement
Probiotic preparation administered orally as adjunctive therapy to conventional antibiotic treatment for the decolonization of intestinal carbapenem-resistant organisms
Conventional AntibioticDrug
Physician-selected antibiotic regimen based on antimicrobial susceptibility testing and clinical indication, administered intravenously or orally at standard therapeutic doses per local antimicrobial stewardship guidelines. Duration ranges from 7 to 14 days depending on clinical response
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Probiotic Adjunctive Therapy Group Receives: Dietary Supplement: Probiotic Preparation; Drug: Conventional Antibiotic |
| Control group | Active comparator | Conventional Antibiotic Therapy Group Receives: Drug: Conventional Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance Rate of Intestinal CRO
Proportion of participants with negative CRO culture from stool samples and negative carbapenemase colloidal gold test at the specified time points. Microbial clearance is defined as the conversion from CRO-positive at baseline to CRO-negative at the assessment visit. The reduction in CRO relative abundance, as measured by fecal metagenomic sequencing, will also be evaluated as a secondary microbiological indicator of clearance.
Measured: Baseline (pre-treatment), during treatment at 1 week, at end of treatment (2 weeks), and at 1 month post-treatment follow-up for recurrence assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterobacteriaceae InfectionsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RONG ZHANG, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707869
- Sponsor's protocol ID
- 2026-0263
- Status last verified
- Feb 2026
- First submitted
- 1 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Study on the Efficacy of Probiotic Preparations as Adjunctive Therapy for Decolonization of Carbapenem-Resistant Enterobacterales
- ClinicalTrials.gov ID
- NCT07707869
- Acronym / sponsor ID
- 2026-0263
- Conditions
- Enterobacteriaceae Infections, Carrier State
- Keywords
- Probiotics, Enterobacterales infection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 16 Jul 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.
To evaluate the efficacy of probiotic preparations as adjunctive therapy for the decolonization of intestinal carbapenem-resistant organisms (CRO), in comparison with conventional antibiotic therapy alone, with the primary endpoints including: (1) the clearance rate of intestinal CRO, defined as negative culture for carbapenem-resistant organisms, and (2) the safety assessment of the treatment, through the documentation of adverse events and potential side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Probiotic Preparation, Drug: Conventional AntibioticProbiotic Adjunctive Therapy Group |
| Control group | Active comparator | Drug: Conventional AntibioticConventional Antibiotic Therapy Group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Laboratory-confirmed intestinal colonization of carbapenem-resistant Enterobacterales, primarily carbapenem-resistant Escherichia coli and Salmonella spp., based on stool culture or rectal swab.
- Hepatic and renal function within normal limits or with only mild abnormalities, as determined by the investigator, to permit safe administration of the intended treatment.
- Able and willing to receive the assigned treatment regimen (either standard antibiotic therapy alone or with adjunctive probiotics) as per the study protocol.
Key exclusion criteria (7 listed)
- Known hypersensitivity or allergy to any excipient of the probiotic preparation, including but not limited to milk/whey, lactose, soy, corn starch, maltodextrin, sweeteners, or flavors.
- Pregnancy or breastfeeding at the time of screening or during the study period.
- Severe chronic organ dysfunction, including but not limited to cardiac, hepatic, or renal failure, that in the investigator's opinion would compromise patient safety or study outcomes.
- Immunocompromised status, including but not limited to active chemotherapy, radiotherapy, solid organ transplantation, hematopoietic stem cell transplantation, or long-term use of immunosuppressive agents.
- Use of concomitant medications that may have serious interactions with the probiotic preparation or that could confound the assessment of the primary outcome, as judged by the investigator.
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 |
|---|---|---|
| Probiotic PreparationProbiotic preparation administered orally as adjunctive therapy to conventional antibiotic treatment for the decolonization of intestinal carbapenem-resistant organisms | Dietary supplement | Experimental Group |
| Conventional AntibioticPhysician-selected antibiotic regimen based on antimicrobial susceptibility testing and clinical indication, administered intravenously or orally at standard therapeutic doses per local antimicrobial stewardship guidelines. Duration ranges from 7 to 14 days depending on clinical response | Drug | Control group, Experimental Group |
Primary outcome
Clearance Rate of Intestinal CRO
Time frame: Baseline (pre-treatment), during treatment at 1 week, at end of treatment (2 weeks), and at 1 month post-treatment follow-up for recurrence assessment.
Proportion of participants with negative CRO culture from stool samples and negative carbapenemase colloidal gold test at the specified time points. Microbial clearance is defined as the conversion from CRO-positive at baseline to CRO-negative at the assessment visit. The reduction in CRO relative abundance, as measured by fecal metagenomic sequencing, will also be evaluated as a secondary microbiological indicator of clearance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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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.
RONG ZHANG principal investigator
Zhejiang University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Preparation and Conventional Antibiotic in people with Enterobacteriaceae Infections and Carrier State, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Clearance Rate of Intestinal CRO (time frame: Baseline (pre-treatment), during treatment at 1 week, at end of treatment (2 weeks), and at 1 month post-treatment follow-up for recurrence assessment.). 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 16 Jul 2026.