Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain
NCT ID: NCT03368105
Last Updated: 2017-12-11
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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UNKNOWN
NA
300 participants
INTERVENTIONAL
2018-01-01
2021-07-01
Brief Summary
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Patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study.
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.
Detailed Description
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The Lactobacillus plantarum 299v (LP299v) is a Gram-positive lactic acid bacteria that naturally occurs on the surface of human intestinal mucosa. Specific properties to the gut mucosa colonization are due to mannose-dependent adhesion of LP299v to the epithelium of human intestines.This ability of LP299v leads to reduction of bacterial translocation from the intestinal lumen into the blood vessels, can prevent adhesion of many pathogens to intestinal epithelium and modulate the inflammatory response of the epithelium. The strain 299v of Lactobacillus plantarum has been found to decrease the severity of gastrointestinal adverse effects during antibiotic therapy. Limited data are available regarding the efficacy of LP299v for preventing Clostridium difficile infections.
Conditions
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Keywords
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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
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.
We will divide participants into two group. Group 1 will receive one capsule of LP299v orally per a day during the entire period of antibiotic therapy. Group 2 will receive one capsule of placebo 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
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.
We will divide participants into two group. Group 1 will receive one capsule of LP299v orally per a day during the entire period of antibiotic therapy. Group 2 will receive one capsule of placebo during the entire period of antibiotic therapy.
Interventions
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Prevention of C. difficile infections using LP299v strain
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.
We will divide participants into two group. Group 1 will receive one capsule of LP299v orally per a day during the entire period of antibiotic therapy. Group 2 will receive one capsule of placebo 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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Central Contacts
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Other Identifiers
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SilesianMUKB-647/2017
Identifier Type: -
Identifier Source: org_study_id