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

NCT06859437 | Recruiting

• 1 other identifier: SilesianMUKB1/78/24
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridioides Difficile Infection

Outcome Measures

Primary Outcomes (1)

• Clostridium difficile infection

  Three month

Study Arms (2)

LP299v group

EXPERIMENTAL

Participants: one capsule of LP299v orally per a day during the entire period of antibiotic therapy.

Dietary Supplement: Prevention of C. difficile infections using LP299v strain LP299v

Placebo group

PLACEBO COMPARATOR

Participants: one capsule of placebo orally per a day during the entire period of antibiotic therapy.

Dietary Supplement: Prevention of C. difficile infections using LP299v strain Placebo

Interventions

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.

Placebo group

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.

LP299v group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years old
• organ transplantation or receiving immunosuppressive drugs for any other reasons
• antibiotics therapy

You may not qualify if:

• no consent to participate in the study

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Department of Nephrology, Transplantation and Intenal Medicine Medical University of Silesia

Poland, Silesian Voivodeship, 40-027, Poland

RECRUITING

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Sylwia Dudzicz-Gojowy, PhD, MD

CONTACT

+48322591432; sdudzicz@sum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

PL (1)