Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department
NCT ID: NCT06859437
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2024-10-01
2027-10-31
Brief Summary
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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.
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Detailed Description
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The study will be conducted among patients hospitalized in the Clinic of Nephrology, Transplantology and Internal Medicine of the Medical University of Silesia/Department of Nephrology, Transplantology and Internal Medicine of the Independent Public Clinical Hospital named after Andrzej Mielęcki of the Medical University of Silesia in Katowice. The study will include patients undergoing immunosuppressive treatment undergoing antibiotic therapy. The exclusion criterion from the study is the lack of consent of the patient to participate in the study.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.
The patient interview will include, among others:
* assessment of gastrointestinal complaints
* assessment of the number of stools per day and their consistency
* incidence of CDI
* incidence of other infectious diseases
The following laboratory and microbiological tests are planned for all patients in the randomized study:
* microbiological assessment of stool before starting treatment
* measurement of C-reactive protein, interleukin 6 and lipopolysaccharide LPS concentration in blood serum and assessment of peripheral blood morphology before starting treatment, on the 7th day of treatment and after 1 month.
* blood culture on MRS Agar before starting treatment, on the 8th-10th day of treatment and after 1 month After 3 months, a telephone interview with the patient is planned to collect information about the occurrence of diarrhea or other gastrointestinal disorders, Clostridioides difficile infection or other infectious diseases in the period of 3 months from the start of probiotic or placebo use.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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LP299v group
Participants: one capsule of LP299v orally per a day during the entire period of antibiotic therapy.
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.
Placebo group
Participants: one capsule of placebo orally per a day during the entire period of antibiotic therapy.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* organ transplantation or receiving immunosuppressive drugs for any other reasons
* antibiotics therapy
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medical University of Silesia
OTHER
Responsible Party
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Locations
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Department of Nephrology, Transplantation and Intenal Medicine Medical University of Silesia
Poland, Silesian Voivodeship, Poland
Countries
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Central Contacts
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Other Identifiers
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SilesianMUKB1/78/24
Identifier Type: -
Identifier Source: org_study_id
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