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Completed

NCT Number: NCT07144124

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

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.

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Key information

Conditions

Cross Infection (Hospital-Acquired Infections) Critical Illness Cross Infection Disease Attributes Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Probiotic Intervention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Fahad Military Medical Complex

Dhahran, Eastern Province, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of ICU-Acquired Infections.

    Time frame: 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 outcomes

  1. Inflammatory Marker Levels (CRP and PCT)

    Time frame: Baseline, Day 5, Day 10, and Day 15

    Monitor changes in serum CRP and PCT levels at different timepoints to evaluate systemic inflammation.

  2. Immunoglobulin Levels (IgG and IgA)

    Time frame: Baseline, Day 5, Day 10, and Day 15

    Monitor changes in serum IgG and IgA levels at different timepoints to assess immune function.

  3. Enteral Feeding Intolerance

    Time frame: 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.

  4. Muscle wasting

    Time frame: Baseline, Day 5, Day 10, and Day 15

    Monitor changes in rectus femoris and vastus intermedius muscle thickness using ultrasound at different timepoint

  5. Mortality

    Time frame: Within 15 days after enrollment.

    Monitor the number of deaths that occur during the study period.

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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