NCT06859437 Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department
| NCT ID | NCT06859437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Silesia |
| Condition | Clostridioides Difficile Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-10-01 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * over 18 years old * organ transplantation or receiving immunosuppressive drugs for any other reasons * antibiotics therapy Exclusion Criteria: * no consent to participate in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06859437 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Clostridioides Difficile Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06859437 currently recruiting?
Yes, NCT06859437 is actively recruiting participants. Contact the research team at sdudzicz@sum.edu.pl for enrollment information.
Where is the NCT06859437 trial being conducted?
This trial is being conducted at Poland, Poland.
Who is sponsoring the NCT06859437 clinical trial?
NCT06859437 is sponsored by Medical University of Silesia. The trial plans to enroll 300 participants.