None listed
Conditions
Interventions
Procedure/Surgery : Detailed Research Methods
1. Enroll patients colonized or infected with vancomycin-resistant Enterococcus (VRE).
2. Collect baseline clinical specimens and administer questionnaire
Sponsors
Inha University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older, both male and female. 2. Individuals who have had VRE detected in stool cultures at least twice. 3. For females, the patient is not breastfeeding and meets at least one of the following criteria: a. Not capable of conceiving (e.g., postmenopausal for over a year, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy resulting in infertility). b. Capable of conceiving and practicing at least one of the following high-efficiency contraceptive methods: barrier methods, oral or non-oral contraceptives, partner with a vasectomy, abstinence from sexual intercourse. The investigator will discuss with the patient to ensure at least one of these methods is followed during the study period. 4. For males with a fertile partner, consent to practice at least one high-efficiency contraceptive method during the study period. 5. If currently taking probiotics, the patient agrees to discontinue their use during the study period.
Exclusion criteria
Exclusion criteria: 1. Patients who require urgent treatment for acute infectious diseases. 2. Female patients who are pregnant, breastfeeding, planning to breastfeed, or planning to become pregnant during the study period. 3. Patients suspected or diagnosed with toxic megacolon or small bowel ileus. 4. Patients currently taking prednisone (or an equivalent dose of steroids) at a dose of 20 mg/day or more, or immunotherapy (e.g., cyclosporine, tacrolimus) at a maintenance dose for more than 2 weeks. 5. Patients who have received antimicrobial treatment other than standard antibiotic therapy for recent CDI within 14 days prior to randomization. 6. Patients with clinically significant comorbidities that, in the investigator's judgment, make them unsuitable for enrollment. 7. Patients who have received investigational drug treatment or participated in an experimental procedure within 1 month prior to enrollment. 8. Patients with a history of fecal microbiota transplantation (FMT). 9. Patients with an absolute neutrophil count of less than 1000/mm³. 10. Patients with known intravenous drug or alcohol abuse, or other substance abuse. 11. Patients who are unable to take the oral formulation of the study drug. 12. Patients receiving intensive induction chemotherapy, radiation therapy, or biological therapy for active malignancy (patients receiving maintenance chemotherapy may be enrolled only after consultation with the medical monitor). 13. Patients unable to comply with the requirements of the study protocol. 14. Conditions that, in the investigator’s judgment, could affect the study objectives. 15. Patients with a life expectancy of 24 weeks or less.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Week-4 vancomycin-resistant Enterococcus (VRE) clearance rate in the high-dose (40 g) FMT group | — |
Secondary
| Measure | Time frame |
|---|---|
| Week-4 VRE clearance rate in the low-dose (20 g) FMT group.;Incidence of adverse events (AEs) and serious adverse events (SAEs) through week 12.;Changes in gut microbiota composition and fecal/blood/urine metabolomic profiles.;Clearance rates of carbapenem-resistant Enterobacterales (CRE) at weeks 4 and 12. | — |
Countries
Korea, Republic of
Contacts
Public ContactJung Hwan Lee
Inha University Hospital
Outcome results
None listed