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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Silesia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

over 18 years old

organ transplantation or receiving immunosuppressive drugs for any other reasons

antibiotics therapy

Disqualifiers

no consent to participate in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prevention of C. difficile infections using LP299v strain Placebo

    Dietary supplement

    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.

  • Prevention of C. difficile infections using LP299v strain LP299v

    Dietary supplement

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: LP299v groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clostridium difficile infection

Time frame
Three month

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Department of Nephrology, Transplantation and Intenal Medicine Medical University of SilesiaRecruiting40-027, Poland, Silesian VoivodeshipPolandPoland

Sponsors and contacts

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