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

NCT ID: NCT07164781

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-12-02

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control group

The (Control group) will receive placebo (sugar tablets)

Group Type: PLACEBO_COMPARATOR

Sugar tablets

Intervention Type: OTHER

The (Control group) will receive placebo (sugar tablets).

Test group

The (Test group) will receive bacillus clausii (Enterogermina) 4 billion every 12h.

Group Type: EXPERIMENTAL

Bacillus clausii

Intervention Type: BIOLOGICAL

The (Test group) will receive bacillus clausii (Enterogermina) 4 billion every 12h.

Interventions

Bacillus clausii

The (Test group) will receive bacillus clausii (Enterogermina) 4 billion every 12h.

Intervention Type: BIOLOGICAL

Sugar tablets

The (Control group) will receive placebo (sugar tablets).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients of both genders aged 18 years or older
• Critically ill patients (medical and surgical) with Acute Physiology and Chronic Health Evaluation II >=10

Exclusion Criteria

• Patients with active cancer/on chemotherapy and/or radiotherapy/autoimmune diseases/ immunomodulating drugs/ neutropenic fever.
• Pregnancy
• Relatives refuse to share in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Doaa kamal Ahmed Ibrahim Qutb

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha University Hospitals

Banhā, Qalyubia Governorate, Egypt

Countries

Egypt

Other Identifiers

MD 10-4-2025

Identifier Type: -

Identifier Source: org_study_id