MedTrace Logo

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

NCT07144124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-08-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Imam Abdulrahman Bin Faisal University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-13
Primary Completion
2024-09-29
Completion
2024-09-29

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07144124 on ClinicalTrials.gov