An interventional study of Bacillus clausii and Sugar tablets in Ventilator Acquired Pneumonia, Catheter Related Bloodstream Infection and Urinary Tract Infection, sponsored by Benha University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Benha University · Not applicable, Interventional, and Prevention
The primary goal of this study is to assess the benefit of probiotics in preventing or minimizing of various type of systemic infection in critically ill adult patients.
Healthcare-associated infections constitute a major focus of public health because of their consequences in terms of mortality, morbidity, and financial costs. Owing to multiple pathophysiological factors, such as immune dysfunction or digestive barrier dysfunction, the critically ill patient is indeed particularly prone to Healthcare-associated infections, often after an early colonization of the digestive tube by resistant bacteria. Among these infections, ventilator-associated pneumonia , with an incidence around 15% and an attributable mortality and other Infections such as sepsis, and urinary tract infections remain among the major causes of worsening of the patient's status or even death in critically ill patients.
Ventilator-associated pneumonia is a common pneumonia occurring more than 48 h after endotracheal intubation in the intensive care unit . The duration of mechanical ventilation is positively correlated with the incidence of ventilator-associated pneumonia. ventilator-associated pneumonia has been reported to occur in approximately 40% of patients experiencing mechanical ventilation. By prolonging the duration of mechanical ventilation and intensive care unit stays and increasing antibiotic demands, Ventilator-associated pneumonia usually negatively impacts the Prognosis of critically ill patients.
Central line-associated bloodstream infections are a source of morbidity and impose an important financial burden. As a public safety net health system, we continually strive to improve the quality of our care and to minimize cost. Every health care associated infection is scrutinized to assess whether it could have been prevented. To our surprise, one patient recently fulfilled the National Healthcare Safety Network surveillance definition for a Central line-associated bloodstream infections in a situation which could have been avoided if Probiotics were more carefully handled.
Urinary tract infection is a common bacterial infection that can lead to significant morbidity including stricture, abscess formation, fistula, bacteremia, sepsis, and pyelonephritis and kidney dysfunction. Mortality rates are reported to be as high as 1% in men and 3% in women due to development of pyelonephritis. Because probiotic therapy is readily available without a prescription, a review of their efficacy in the prevention of Urinary tract infection may aid consumers in making informed decisions about potential prophylactic therapy.
420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.
This study's planned enrollment of 100 is below the median of 115 across 276 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The (Control group) will receive placebo (sugar tablets)
Other: Sugar tablets
The (Test group) will receive bacillus clausii (Enterogermina) 4 billion every 12h.
Biological: Bacillus clausii
The (Test group) will receive bacillus clausii (Enterogermina) 4 billion every 12h.
The (Control group) will receive placebo (sugar tablets).
Occurrence of systemic infections
Time frame: one month
ICU length of stay
Time frame: one month
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Sep 2025, 5 months after the start.
Of 81 non-industry interventional studies with no phase under Pneumonia, Ventilator-Associated, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 5 months is below that.
Counting every sponsor, half of 82 studies reached it within 20 months; a quarter within 10 and three quarters within 36.
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Studies of the drug tested here: Bacillus clausii
Pneumonia, Ventilator-Associated →