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

NCT07144124 | Completed

• 1 other identifier: 2024-77
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of ICU-Acquired Infections.

  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.

  Within 15 days from enrollment or until ICU discharge, whichever occurs first.

Secondary Outcomes (5)

• Inflammatory Marker Levels (CRP and PCT)

  Baseline, Day 5, Day 10, and Day 15

• Immunoglobulin Levels (IgG and IgA)

  Baseline, Day 5, Day 10, and Day 15

• Enteral Feeding Intolerance

  Daily for 15 days or until ICU discharge

• Muscle wasting

  Baseline, Day 5, Day 10, and Day 15

• Mortality

  Within 15 days after enrollment.

Study Arms (2)

Arm1: Control Group - Standard ICU Care

NO INTERVENTION

Participants in this arm will receive standard ICU care according to institutional protocols. No probiotic supplementation will be administered.

Probiotic Group - Standard Care Plus Biopro-Max

EXPERIMENTAL

Participants in this arm will receive standard ICU care according to institutional protocols plus Biopro-Max 8 Billion Probiotics (Bioserv Healthcare). The supplement will be administered as one bottle per day for 15 consecutive days.

Dietary Supplement: Biopro-max 8 Billion Probiotics (Bioserv Healthcare)

Interventions

Biopro-max 8 Billion Probiotics (Bioserv Healthcare) DIETARY_SUPPLEMENT

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.

Probiotic Group - Standard Care Plus Biopro-Max

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

King Fahad Military Medical Complex

Dhahran, Eastern Province, Saudi Arabia

Location

MeSH Terms

Conditions

Cross Infection; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Master's Candidate in Clinical Nutrition, and Clinical Dietitian at Almana Medical Center - Rakah

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: February 13, 2024
• Primary Completion: September 29, 2024
• Study Completion: September 29, 2024
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)