New hope against superbugs: gut cleanse trial launches

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects aged ≥19 years and \<65 years * Subjects with confirmed intestinal colonization of Carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococcus (VRE) at ≥10⁴ CFU per gram of stool at Visit 1 * Subjects who are carriers of CRE or VRE at Visit 1 and do not require treatment for CRE or VRE infection * Subjects who are able to read and understand the informed consent document and agree to provide stool samples * Subjects who voluntarily agree to participate in the study prior to initiation and provide written informed consent (Informed Consent Form) Exclusion Criteria: * Subjects whose CRE or VRE colonization in stool at Visit 2 has decreased by ≥10² CFU per gram compared to Visit 1 * Subjects with the following medical conditions or history: * History of solid organ transplantation (e.g., heart, kidney, lung) * Neutropenia * Septic shock due to systemic inflammatory response syndrome (SIRS) or sepsis with persistent hypotension (systolic blood pressure \<90 mmHg) * Toxic megacolon or small bowel obstruction * History of colectomy or colon resection ⑥ History of fecal microbiota transplantation (FMT) * Epilepsy (seizure disorder), or history of recurrent seizures or cardiac arrest * Severe anaphylaxis ⑨ Major gastrointestinal surgery (e.g., gastrectomy) within 3 months prior to Visit 1 (Appendectomy or cholecystectomy are allowed) ⑩ History of bacteremia within 2 weeks prior to Visit 1 ⑪ Pitt bacteremia score ≥4 * Subjects currently admitted to the intensive care unit (ICU) or requiring ICU admission due to severe illness * Subjects requiring mechanical ventilation or vasopressor support (e.g., norepinephrine, ephedrine) * Subjects receiving active treatment (chemotherapy, radiotherapy, biologic therapy, or maintenance chemotherapy) for active malignancy (including metastatic cancer) * Subjects requiring treatment for central nervous system infections (e.g., meningitis, encephalitis, shunt infection) * Subjects undergoing peritoneal dialysis * Subjects with diarrhea caused by Clostridioides difficile infection * Subjects with comorbidities that may pose risks during endoscopy or colonoscopy * Severely immunocompromised subjects * Subjects receiving high-dose immunosuppressants (e.g., glucocorticoids, azathioprine, 6-mercaptopurine, methotrexate, tacrolimus, cyclosporine, mycophenolate mofetil)(Participation may be allowed if deemed not to affect study outcomes by the investigator after review of dose, drug, and duration) * Subjects requiring antibiotic or related treatment due to severe infection, or planning to use antibiotics during the study period * Subjects who have taken gastric acid suppressants (e.g., PPIs), antibiotics, antidiarrheal agents, probiotics, prebiotics, or lactic acid bacteria products (≥4 times per week) within 1 week prior to Visit 1 * Subjects with BMI \<17 kg/m² at Visit 1 * Subjects with clinically significant abnormal laboratory findings: * Hemoglobin (Hb) \< 8.0 g/dL ② Platelet count (PLT) \< 75,000/mm³ * AST or ALT ≥3× the upper limit of normal (ULN) * Total bilirubin \>2× ULN ⑤ Albumin \<3.2 mg/dL ⑥ Serum creatinine \>2× ULN ⑦ HbA1c \>8.0% * Subjects with a life expectancy of less than 6 months * Subjects unwilling or unable to use adequate contraception during the study period; Acceptable contraception methods include: intrauterine device (IUD/IUS), sterilization (vasectomy or tubal ligation), or dual barrier methods (e.g., cervical cap or diaphragm with male condom) * Pregnant or breastfeeding women, or those planning pregnancy during the study period * Subjects who participated in another interventional clinical trial within 3 months prior to Visit 1, or plan to participate in another interventional clinical trial during this study * Subjects with hypersensitivity or allergy to food components or investigational product (IP) components * Subjects deemed unsuitable for participation by the investigator for any other reason