Status:
UNKNOWN
Efficacy of a Probiotic or Fecal Microbiota Transplantation (FMT) on the Eradication of Rectal Multidrug-resistant Gram-negative Bacilli (MDR-GNB) Carriage (PROFTMDECOL)
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Fundacion Clinic per a la Recerca Biomédica
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Conditions:
CARRIER STATE
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The working hypothesis is that in patients who are rectal carriers of MDR-GNB (Multi drug-resistant gram negative bacilli), the rate and speed of eradication of the carrier status obtained with NAA re...
Detailed Description
Data Collection and Processing Recording of data All data required for the study will be recorded in the participating center using a case report form (CRF). Completeness and plausibility checks will...
Eligibility Criteria
Inclusion
- Adult patients (≥18 years-old).
- 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).
- Eligible for routine digestive decolonization (7 days oral administration of nonabsorbable antibiotics (NAA).
- Capable to provide informed consent (by themselves or through their legal representatives).
Exclusion
- Pregnant women or breastfeeding.
- Neutropenic patients (total neutrophil count \<500 cell/mm3)\*.
- HIV-infected patients with CD4(cluster of differentiation 4) count \<200 cell/mm3.
- Patients with active C. difficile infection.
- Patients with ileus or bowel obstruction.
- Patients with documented or suspected bowel perforation.
- 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.
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT04431934
Start Date
November 16 2020
End Date
July 1 2023
Last Update
February 12 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clinic
Barcelona, Spain, 08003