Probiotics for Preventing ICU-Acquired Infections in Critically Ill Patients: A Pilot Study
- Conditions
- Cross Infection (Hospital-Acquired Infections)Critical IllnessProbiotic Intervention
- Registration Number
- NCT07144124
- Lead Sponsor
- Imam Abdulrahman Bin Faisal University
- Brief Summary
This pilot randomized clinical trial investigated the effect of probiotic supplementation on the incidence of intensive care unit-acquired infections (ICU-AIs) in critically ill patients. ICU-AIs are a major complication in patients receiving mechanical ventilation and enteral nutrition, contributing to increased morbidity, prolonged ICU length of stay, and higher mortality rates.
The objective of this study was to assess whether daily administration of a probiotic supplement, in addition to standard ICU care, could reduce the risk of ICU-AIs compared with standard care alone. Eligible participants were critically ill adults who were mechanically ventilated and receiving enteral feeding. Patients were randomly assigned to one of two groups:
Control group: standard ICU care. Intervention group: standard ICU care plus probiotic supplementation (Biopro-max 8 Billion Probiotics (Bioserv Healthcare)).
The intervention continued for 15 days, during which participants were monitored daily for the occurrence of ICU-AIs confirmed by the treating ICU physician. Secondary outcomes included inflammatory and immune markers (CRP, PCT, IgG, IgA), tolerance to enteral feeding, skeletal muscle changes assessed by point-of-care ultrasound, ICU and hospital length of stay, and mortality.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Enrolled patients were critically ill adults aged 18 years or older, had initiated enteral nutrition (EN) within 48 hours of ICU admission, were required mechanical ventilation and were anticipated to remain ventilated for at least five days.
- Patients were excluded if they had been mechanically ventilated for more than 72 hours before enrollment; had an absolute neutrophil count under 500/mm³; had received antibiotics for more than three days before screening; had received immunosuppressants within one week prior to enrollment or had a diagnosis of immunosuppressive disease; had end-stage cancer; had previously received probiotics, prebiotics, or synbiotics before screening; were pregnant or lactating; or had not received the first dose of probiotics within 48 hours following ICU admission.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of ICU-Acquired Infections. Within 15 days from enrollment or until ICU discharge, whichever occurs first. ICU-acquired infections are defined as infections that were not present or detected at ICU admission but occurred during the ICU stay. Infections were confirmed by the attending ICU physician.
- Secondary Outcome Measures
Name Time Method Immunoglobulin Levels (IgG and IgA) Baseline, Day 5, Day 10, and Day 15 Monitor changes in serum IgG and IgA levels at different timepoints to assess immune function.
Inflammatory Marker Levels (CRP and PCT) Baseline, Day 5, Day 10, and Day 15 Monitor changes in serum CRP and PCT levels at different timepoints to evaluate systemic inflammation.
Enteral Feeding Intolerance Daily for 15 days or until ICU discharge Monitor the occurrence of enteral feeding intolerance based on gastric residual volume, abdominal distention, vomiting, diarrhea, and use of prokinetic drugs.
Muscle wasting Baseline, Day 5, Day 10, and Day 15 Monitor changes in rectus femoris and vastus intermedius muscle thickness using ultrasound at different timepoint
Mortality Within 15 days after enrollment. Monitor the number of deaths that occur during the study period.
Trial Locations
- Locations (1)
King Fahad Military Medical Complex
🇸🇦Dhahran, Eastern Province, Saudi Arabia
King Fahad Military Medical Complex🇸🇦Dhahran, Eastern Province, Saudi Arabia