RecruitingNot ApplicableNCT06859437

Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department


Sponsor

Medical University of Silesia

Enrollment

300 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study was to analyze whether the use of the LP299v strain reduces the risk of Clostridium difficile infection (CDI) among patients receiving antibiotics and hospitalized in the nephrology and transplantation ward. Adutt patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study. Patients who meet the above criteria for inclusion in the study will be assigned to one of two groups. Patients in group I (study) will receive a probiotic containing the Lactobacillus plantarum 299v strain of bacteria as part of the prophylaxis of Clostridioides difficile infection. The daily dose is 1 capsule containing approximately 10x109 colony-forming units of live bacteria taken orally with a meal. Patients in group II (control) will receive a placebo. The duration of probiotic or placebo use will be 3 months. Assignment to groups I and II will be random. The number of patients in each group will be 150. Participants will be divided into two groups. First group will receive one capsule of Lactobacillus plantarum 299v (LP299v) orally per a day. Second group will receive placebo. The observation period will last 3 months. The evaluation will consist of an interview, physical examination and laboratory tests.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • over 18 years old
  • organ transplantation or receiving immunosuppressive drugs for any other reasons
  • antibiotics therapy

Exclusion Criteria1

  • no consent to participate in the study

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Interventions

DIETARY_SUPPLEMENTPrevention of C. difficile infections using LP299v strain Placebo

Patients treated with antibiotics and at high CDI risk (patients after organ transplantation or receiving immunosuppressive therapy for any other reason) will be enroll to study. One capsule of placebo orally per a day during the entire period of antibiotic therapy.

DIETARY_SUPPLEMENTPrevention of C. difficile infections using LP299v strain LP299v

Patients treated with antibiotics and at high CDI risk (patients after organ transplantation or receiving immunosuppressive therapy for any other reason) will be enroll to study. One capsule of LP299v orally per a day during the entire period of antibiotic therapy.


Locations(1)

Department of Nephrology, Transplantation and Intenal Medicine Medical University of Silesia

Poland, Silesian Voivodeship, Poland

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NCT06859437


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