Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT03944369
Eligibility Criteria:
Inclusion Criteria:
* Be male or female, ≥18 years of age
* Positive stool culture for at least one of these three organisms: VRE, ESBLE or CRE
* Be willing and able to give informed consent
* If taking probiotic or prebiotic dietary supplements, usage must be consistent within 7 days prior to the run-in phase and willing to remain consistent throughout the study
* If subject is female: subject is surgically sterile or post-menopausal (12 months with no menses without an alternate medical cause); or if subject is a female of childbearing potential, must have a negative urine pregnancy test at Screening, must not be lactating, and must agree to abstain from sexual activity or agree to use one highly effective method of contraception for the duration of the study
Exclusion Criteria:
* Planned escalation of immunosuppression
* Neutropenia (≤500 absolute neutrophil count per μL)
* Allogenic stem cell transplant recipients with ongoing gastrointestinal disease
* Rapidly progressive or terminal illness
* Hemodynamic instability, or any other significant systemic, unstable or untreated disease
* Currently receiving or anticipated to require systemic (oral or IV anti-infective) or gut-directed antibacterial therapy
* Recent history of the following conditions requiring medical attention: known or suspected gastrointestinal (GI) infection (e.g., viral or bacterial gastroenteritis) or inflammatory bowel disease
* Major intra-abdominal surgery related to the bowel within the 3 months prior to Run-In
* Receiving total parenteral nutrition
* Contraindications, sensitivity, or known allergy to the use of the study product or its components
* Individuals who, in the opinion of the Investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study procedures (e.g., planned procedures)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03944369
Study Brief:
Protocol Section:
NCT03944369