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

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.
• 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.