Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06859437

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

Led by Medical University of Silesia · Updated on 2025-03-05

300

Participants Needed

1

Research Sites

160 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years old
  • Have had an organ transplant or are receiving immunosuppressive drugs for any reason
  • Are currently receiving antibiotic therapy
Not Eligible

You will not qualify if you...

  • Do not consent to participate in the study

AI-Screening

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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

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Research Team

S

Sylwia Dudzicz-Gojowy, PhD, MD

CONTACT

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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