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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT03834051
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older.
* Able to provide informed consent.
* Willing and able to comply with all the required study procedures.
* Rectally colonized with antimicrobial resistant organisms: Extended-spectrum of beta-lactamase, Carbapenem resistant, vancomycin resistant enterococci
Exclusion Criteria:
* Planned or actively taking another investigational product
* Patients with neutropenia with absolute neutrophil count \<0.5 x 109/L
* Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
* Peripheral white blood cell count \> 30.0 x 109/L AND temperature \> 38.0 ºC
* Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia or Campylobacter.
* Unable to tolerate FMT or enema for any reason.
* Requiring systemic antibiotic therapy at the time of FMT.
* Actively taking Saccharomyces boulardii or other probiotic; yogurt is allowed
* Severe underlying disease such that the patient is not expected to survive for at least 30 days.
* History of severe allergy to any food
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03834051
Study Brief:
Protocol Section:
NCT03834051