Cross Infection (Hospital-Acquired Infections)NCT07144124
Probiotics for Preventing ICU-Acquired Infections in Critically Ill Patients: A Pilot Study
A study testing Biopro-max 8 Billion Probiotics (Bioserv Healthcare) in people with Cross Infection (Hospital-Acquired Infections) and Critical Illness, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cross Infection (Hospital-Acquired Infections), Critical Illness, Probiotic Intervention
- What is being tested?
- Biopro-max 8 Billion Probiotics (Bioserv Healthcare)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 13 Feb 2024to 29 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Fahad Military Medical Complex
Dhahran, Eastern Province
About this study
Official 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
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:
Read more
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.
- Being tested
- Biopro-max 8 Billion Probiotics (Bioserv Healthcare)
- Medical subject headings
- Cross Infection, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Biopro-max 8 Billion Probiotics (Bioserv Healthcare) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 15 days from enrollment or until ICU discharge, whichever occurs first.
Secondary outcomes (5)
Inflammatory Marker Levels (CRP and PCT)
Monitor changes in serum CRP and PCT levels at different timepoints to evaluate systemic inflammation.
Measured: Baseline, Day 5, Day 10, and Day 15
Immunoglobulin Levels (IgG and IgA)
Monitor changes in serum IgG and IgA levels at different timepoints to assess immune function.
Measured: 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.
Measured: 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
Measured: Baseline, Day 5, Day 10, and Day 15
Mortality
Monitor the number of deaths that occur during the study period.
Measured: Within 15 days after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start13 Feb 2024
- Primary completion29 Sep 2024
- Study completion29 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross Infection (Hospital-Acquired Infections)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aqdar Mufareh Al Aklabi, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144124
- Sponsor's protocol ID
- 2024-77
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the small sample size and privacy concerns.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07144124
- Acronym / sponsor ID
- 2024-77
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 29 Sep 2024 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Biopro-max 8 Billion Probiotics (Bioserv Healthcare)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Probiotic Group - Standard Care Plus Biopro-Max |
Primary outcome
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.
5 secondary outcomes
Inflammatory Marker Levels (CRP and PCT)
Time frame: Baseline, Day 5, Day 10, and Day 15
Immunoglobulin Levels (IgG and IgA)
Time frame: Baseline, Day 5, Day 10, and Day 15
Enteral Feeding Intolerance
Time frame: Daily for 15 days or until ICU discharge
Muscle wasting
Time frame: Baseline, Day 5, Day 10, and Day 15
Mortality
Time frame: Within 15 days after enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the small sample size and privacy concerns.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopro-max 8 Billion Probiotics (Bioserv Healthcare) in people with Cross Infection (Hospital-Acquired Infections) and Critical Illness, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ICU-Acquired Infections. (time frame: Within 15 days from enrollment or until ICU discharge, whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.