An interventional study of Prevention of C. difficile infections using LP299v strain in Clostridium Difficile, sponsored by Medical University of Silesia. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-11.
Sponsored by Medical University of Silesia · Not applicable, Interventional, and Prevention
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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.
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.
Clostridium difficile is currently the most frequently identified pathogen causing antibiotic-associated diarrhoea and the main cause of nosocomial diarrhoea. In regard to observed worldwide increase rate of infection and mortality from CDI the prevention of Clostridium difficile infections seems to be crucial, especially in patients at CDI high risk. So far, it has not been unambiguously proven that probiotics are effective in the prevention of Clostridium difficile infection among patients undergoing antibiotic therapy.
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.
251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
This study's planned enrollment of 300 is above the median of 64 across 185 interventional studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →Medical University of Silesia is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Clostridium difficile infection
Time frame: During hospitalization - average of 14 days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2018; primary completion for Jan 2021, 36 months later.
Of 27 interventional studies with no phase under Clostridium Infections, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's planned 36 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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