NCT07164781

Effect of Use of Probiotics on Systemic Infection in Critically Ill Patients: a Double Blind, Randomized, Placebo-controlled Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ventilator Acquired Pneumonia
• Catheter Related Bloodstream Infection
• Urinary Tract Infection
• Diarrhea
• Probiotics

Interventions

Type	Name	Description
BIOLOGICAL	Bacillus clausii	The (Test group) will receive bacillus clausii (Enterogermina) 4 billion every 12h.
OTHER	Sugar tablets	The (Control group) will receive placebo (sugar tablets).

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-09-01
• Completion: 2025-12-02
• First posted: 2025-09-10
• Last updated: 2025-09-10

Locations

1 site across 1 country: Egypt