Study of Probiotic Adjunctive Therapy for Decolonization of Carbapenem-Resistant Enterobacterales

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.

Inclusion Criteria:

1. Laboratory-confirmed intestinal colonization of carbapenem-resistant Enterobacterales, primarily carbapenem-resistant Escherichia coli and Salmonella spp., based on stool culture or rectal swab.
2. 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.
3. 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:

1. 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.
2. Pregnancy or breastfeeding at the time of screening or during the study period.
3. 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.
4. Immunocompromised status, including but not limited to active chemotherapy, radiotherapy, solid organ transplantation, hematopoietic stem cell transplantation, or long-term use of immunosuppressive agents.
5. 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.
6. 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.
7. Inability or unwillingness to comply with the study visit schedule or other protocol requirements.