Study of Probiotic Adjunctive Therapy for Decolonization of Carbapenem-Resistant Enterobacterales (NCT07707869) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study of Probiotic Adjunctive Therapy for Decolonization of Carbapenem-Resistant Enterobacterales
China20 participantsStarted 2026-03-01
Plain-language 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 carbapenem-resistant organisms, and (2) the safety assessment of the treatment, through the documentation of adverse events and potential side effects.
Who can participate
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
. 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.
Exclusion criteria
. 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.
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
Clearance Rate of Intestinal CRO
Timeframe: 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.
Trial details
NCT IDNCT07707869
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
. 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.