Actively Recruiting
Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v in Nephrology and Transplantation Department
Led by Medical University of Silesia · Updated on 2025-03-05
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate if using the Lactobacillus plantarum 299v (LP299v) strain can lower the risk of Clostridium difficile infection (CDI) in adults who are in a high-risk group. These patients are hospitalized in a nephrology and transplantation ward and are receiving immunosuppressive drugs along with antibiotic therapy. The study is prospective and planned to recruit 300 patients over a period from October 2024 to October 2027. Participants will be randomly assigned to one of two groups. One group will receive a daily oral capsule of the probiotic LP299v containing approximately 10 billion live bacteria, while the other group will receive a placebo capsule. Both treatments will be taken with a meal for three months during their antibiotic therapy. The study includes a three-month observation period to monitor the effects. During the study, participants will have interviews to assess gastrointestinal symptoms and infections. Physical examinations and laboratory tests will be conducted, including stool microbiology and blood markers like C-reactive protein and interleukin 6 at multiple time points. After the three-month treatment and observation, a telephone interview will collect further information on gastrointestinal health and infections. The main outcome measured will be the occurrence of Clostridium difficile infection within three months.
CONDITIONS
Brief Title
Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years old
- Organ transplantation or receiving immunosuppressive drugs for any reason
- Currently undergoing antibiotic therapy
You will not qualify if you...
- No consent to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of antibiotic therapy, up to 3 months
Participants take one capsule of either Lactobacillus plantarum 299v or placebo orally each day during their antibiotic therapy to help prevent Clostridium difficile infections.
Visits at treatment start, day 7, day 8-10, and 1 month for assessments
Duration - Up to 3 months after treatment start
After treatment, participants will be contacted by phone to collect information about gastrointestinal symptoms and infections occurring during the 3 months following the start of treatment.
1 telephone interview
Trial Site Locations
Total: 1 location
1
Department of Nephrology, Transplantation and Intenal Medicine Medical University of Silesia
Poland, Silesian Voivodeship, Poland, 40-027
Actively Recruiting
Research Team
S
Sylwia Dudzicz-Gojowy, PhD, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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