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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Marker Levels (CRP and PCT) | Monitor changes in serum CRP and PCT levels at different timepoints to evaluate systemic inflammation. | Baseline, Day 5, Day 10, and Day 15 |
| Immunoglobulin Levels (IgG and IgA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Fahad Military Medical Complex | Dhahran | Eastern Province | Saudi Arabia |
Individual participant data will not be shared due to the small sample size and privacy concerns.
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|
Monitor changes in serum IgG and IgA levels at different timepoints to assess immune function.
| Baseline, Day 5, Day 10, and Day 15 |
| Enteral Feeding Intolerance | Monitor the occurrence of enteral feeding intolerance based on gastric residual volume, abdominal distention, vomiting, diarrhea, and use of prokinetic drugs. | Daily for 15 days or until ICU discharge |
| Muscle wasting | Monitor changes in rectus femoris and vastus intermedius muscle thickness using ultrasound at different timepoint | Baseline, Day 5, Day 10, and Day 15 |
| Mortality | Monitor the number of deaths that occur during the study period. | Within 15 days after enrollment. |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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