Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae

  • End date
    Sep 1, 2024
  • participants needed
  • sponsor
    Maimónides Biomedical Research Institute of Córdoba
Updated on 18 October 2021


Infections caused by carbapenemase-producing Enterobacteriaceae are frequent and often associated with high rates of mortality. Colonized patients are at increased risk of infection for these microorganisms. Moreover, they can act as a reservoir facilitating the transmission to other patients. To date, decolonization strategies with antibiotics have not obtained convincing results. For that reason our main objective is to investigate the efficacy of fecal microbiota transplantation (FMT) for selective intestinal decolonization of patients colonized by KPC-producing Klebsiella pneumoniae (Kp-KPC) at 30 days after FMT. Our hypothesis is that FMT is effective and safe for selective intestinal decolonization in patients colonized by Kp-KPC. The design of the study is a randomized, superiority, double blind controlled with placebo clinical trial.

The main variable is the percentage of patients with intestinal decolonization at 30 days after FMT in intention to treat population (all randomized patients). Decolonization will be considered as the abscence of isolation of Kp-KPC in culture from rectal swab together with the abscence of detection of carbapenemase by mean of polymerase chain reaction.

Secondary objectives are:

  • To evaluate the safety of FMT.
  • To determine if FMT is associated with decrease in the amount of bacteria at 7 days after FMT and 30 days after FMT.
  • To evaluate if FMT is associated with persistent intestinal decolonization at 3 months after intervention.
  • To study if FMT is associated with decrease in the incidence of Kp-KPC infections at 3 months after intervention.
  • To evaluate if FMT is associated with decrease in mortality due to Kp-KPC infections at 3 months after intervention.

Condition Carbapenemase-producing Enterobacteriaceae Infection
Treatment Placebo, Fecal Microbiota Transplantation
Clinical Study IdentifierNCT04760665
SponsorMaimónides Biomedical Research Institute of Córdoba
Last Modified on18 October 2021


Yes No Not Sure

Inclusion Criteria

Age> = 18 years
Signature of the informed consent by the patient or legally designated person
Absence of active infection by carbapenemase-type KPC-producing Klebsiella pneumoniae at the time of assessment as well as in the month prior to inclusion in the study

Exclusion Criteria

Terminal situation, or estimated life expectancy of less than 3 months
Pregnant or lactating women
Intolerance or inability to take oral medication at the time of assessment
History of aspiration or dysphagia
Patients with a history of colectomy, colostomy or ileostomy
Patients who are receiving or have received antibiotics in the month prior to the inclusion assessment
Neutrophil count less than 500 cells / mm3
Anticipation of the use of myelosuppressive treatment (eg. dexamethasone, chemotherapy against to solid tumors or prior to transplantation of hematopoietic progenitories) within 30 days after inclusion in the study
Hematopoietic stem cell transplantation in the month prior to inclusion in the study
Presence of clinical signs of mucositis
Forecast of major abdominal surgical intervention in the month following inclusion in the study
Patients with a Gianella Score> 12 points
History of having received decolonization guidelines in the previous 3 months
Severe food allergy
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note