NCT07144124

Probiotics for Preventing ICU-Acquired Infections in Critically Ill Patients: A Pilot Study

The Effect of Probiotic Supplementation on the Incidence of ICU-Acquired Infections Among Enterally Fed Patients: A Single-Center, Randomized, Open-Label, Controlled Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Imam Abdulrahman Bin Faisal University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cross Infection (Hospital-Acquired Infections)
• Critical Illness
• Probiotic Intervention

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Biopro-max 8 Billion Probiotics (Bioserv Healthcare)	Participants in the intervention arm will receive Biopro-Max 8 Billion Probiotics (Bioserv Healthcare). The supplement will be administered as one bottle per day for 15 consecutive days in addition to standard ICU care. The intervention is intended to evaluate whether daily probiotic supplementation reduces the incidence of ICU-acquired infections and improves related clinical outcomes, including inflammatory and immune markers, feeding tolerance, muscle changes, and mortality.

Timeline

• Start date: 2024-02-13
• Primary completion: 2024-09-29
• Completion: 2024-09-29
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

1 site across 1 country: Saudi Arabia