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

Imam Abdulrahman Bin Faisal University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07144124

2024-77

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Arm1: Control Group - Standard ICU Care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

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