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

NCT06859437 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-03-05

No results posted yet for this study

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.

Conditions

  • Clostridioides Difficile Infection

Interventions

DIETARY_SUPPLEMENT

Prevention 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_SUPPLEMENT

Prevention 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.

Sponsors & Collaborators

  • Medical University of Silesia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • Poland

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06859437 on ClinicalTrials.gov