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:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT04431934
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients (≥18 years-old).
2. Admitted to the Hospital Clinic of Barcelona with documented rectal colonization whitin the previous 7 days by rectal swabbing with MDR-GNB (ESBL-producing Klebsiella pneumoniae, carbapenemase-producing Enterobacterial (CPE) and MDR/XDR Pseudomonas aeruginosa).
3. Eligible for routine digestive decolonization (7 days oral administration of nonabsorbable antibiotics (NAA).
4. Capable to provide informed consent (by themselves or through their legal representatives).
Exclusion Criteria:
1. Pregnant women or breastfeeding.
2. Neutropenic patients (total neutrophil count \<500 cell/mm3)\*.
3. HIV-infected patients with CD4(cluster of differentiation 4) count \<200 cell/mm3.
4. Patients with active C. difficile infection.
5. Patients with ileus or bowel obstruction.
6. Patients with documented or suspected bowel perforation.
7. Patients with a colistin-resistant MDR-GNB.
* Solid organ or hematopoietic organ transplant recipients without neutropenia will qualify for inclusion in the study. This is based on preliminary data on the safety of probiotics without Saccharomyces boulardii/cerevisae in transplant recipients of several organs (hematopoietic precursors, liver, kidney, small intestine) and on the preliminary safety data of FMT in nonneutropenic patients with hematological disorders including hematopoietic cell transplantation (25,42,43). However, the condition of transplant recipients will be assessed inan individual basis and only those patients that by consensus with their attending physician will be judged to be at a very low risk of complications derived from the use of the probiotic o fecal microbiota will be considered for inclusion in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04431934
Study Brief:
Protocol Section:
NCT04431934