Ventilator Acquired PneumoniaNCT07164781
Effect of Use of Probiotics on Systemic Infection in Critically Ill Patients: a Double Blind, Randomized, Placebo-controlled Trial
A study testing Bacillus clausii and Sugar tablets in people with Ventilator Acquired Pneumonia and Catheter Related Bloodstream Infection, run by Benha University at 1 site in Egypt.
Trial summary
The primary goal of this study is to assess the benefit of probiotics in preventing or minimizing of various type of systemic infection in critically ill adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Acquired Pneumonia, Catheter Related Bloodstream Infection, Urinary Tract Infection
- What is being tested?
- Bacillus clausii and Sugar tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 2 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients of both genders aged 18 years or older
- Critically ill patients (medical and surgical) with Acute Physiology and Chronic Health Evaluation II >=10
Who cannot join
- Patients with active cancer/on chemotherapy and/or radiotherapy/autoimmune diseases/ immunomodulating drugs/ neutropenic fever.
- Pregnancy
- Relatives refuse to share in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The primary goal of this study is to assess the benefit of probiotics in preventing or minimizing of various type of systemic infection in critically ill adult patients.
Read the detailed description
Healthcare-associated infections constitute a major focus of public health because of their consequences in terms of mortality, morbidity, and financial costs. Owing to multiple pathophysiological factors, such as immune dysfunction or digestive barrier dysfunction, the critically ill patient is indeed particularly prone to Healthcare-associated infections, often after an early colonization of the digestive tube by resistant bacteria. Among these infections, ventilator-associated pneumonia , with an incidence around 15% and an attributable mortality and other Infections such as sepsis, and urinary tract infections remain among the major causes of worsening of the patient's status or even death in critically ill patients.
Ventilator-associated pneumonia is a common pneumonia occurring more than 48 h after endotracheal intubation in the intensive care unit . The duration of mechanical ventilation is positively correlated with the incidence of ventilator-associated pneumonia. ventilator-associated pneumonia has been reported to occur in approximately 40% of patients experiencing mechanical ventilation. By prolonging the duration of mechanical ventilation and intensive care unit stays and increasing antibiotic demands, Ventilator-associated pneumonia usually negatively impacts the Prognosis of critically ill patients.
Central line-associated bloodstream infections are a source of morbidity and impose an important financial burden. As a public safety net health system, we continually strive to improve the quality of our care and to minimize cost. Every health care associated infection is scrutinized to assess whether it could have been prevented. To our surprise, one patient recently fulfilled the National Healthcare Safety Network surveillance definition for a Central line-associated bloodstream infections in a situation which could have been avoided if Probiotics were more carefully handled.
Urinary tract infection is a common bacterial infection that can lead to significant morbidity including stricture, abscess formation, fistula, bacteremia, sepsis, and pyelonephritis and kidney dysfunction. Mortality rates are reported to be as high as 1% in men and 3% in women due to development of pyelonephritis. Because probiotic therapy is readily available without a prescription, a review of their efficacy in the prevention of Urinary tract infection may aid consumers in making informed decisions about potential prophylactic therapy.
- Conditions
- Ventilator Acquired Pneumonia, Catheter Related Bloodstream Infection, Urinary Tract Infection, Diarrhea, Probiotics
- Being tested
- Bacillus clausii, Sugar tablets
- Keywords
- Probiotic, Systemic infection
- Medical subject headings
- Pneumonia, Ventilator-Associated, Urinary Tract Infections, Diarrhea, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus clausiiBiological
The (Test group) will receive bacillus clausii (Enterogermina) 4 billion every 12h.
Sugar tabletsOther
The (Control group) will receive placebo (sugar tablets).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The (Control group) will receive placebo (sugar tablets) Receives: Other: Sugar tablets |
| Test group | Experimental | The (Test group) will receive bacillus clausii (Enterogermina) 4 billion every 12h. Receives: Biological: Bacillus clausii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of systemic infections
Measured: one month
Secondary outcomes (1)
ICU length of stay
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Apr 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion2 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa kamal Ahmed Ibrahim Qutb, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164781
- Sponsor's protocol ID
- MD 10-4-2025
- Status last verified
- Jun 2025
- First submitted
- 24 May 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Use of Probiotics on Systemic Infection in Critically Ill Patients: a Double Blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07164781
- Acronym / sponsor ID
- MD 10-4-2025
- Conditions
- Ventilator Acquired Pneumonia, Catheter Related Bloodstream Infection, Urinary Tract Infection, Diarrhea, Probiotics
- Keywords
- Probiotic, Systemic infection
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 2 Dec 2025 (estimated)
- First posted
- 10 Sep 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.
The primary goal of this study is to assess the benefit of probiotics in preventing or minimizing of various type of systemic infection in critically ill adult patients.
Detailed description
Healthcare-associated infections constitute a major focus of public health because of their consequences in terms of mortality, morbidity, and financial costs. Owing to multiple pathophysiological factors, such as immune dysfunction or digestive barrier dysfunction, the critically ill patient is indeed particularly prone to Healthcare-associated infections, often after an early colonization of the digestive tube by resistant bacteria. Among these infections, ventilator-associated pneumonia , with an incidence around 15% and an attributable mortality and other Infections such as sepsis, and urinary tract infections remain among the major causes of worsening of the patient's status or even death in critically ill patients.
Ventilator-associated pneumonia is a common pneumonia occurring more than 48 h after endotracheal intubation in the intensive care unit . The duration of mechanical ventilation is positively correlated with the incidence of ventilator-associated pneumonia. ventilator-associated pneumonia has been reported to occur in approximately 40% of patients experiencing mechanical ventilation. By prolonging the duration of mechanical ventilation and intensive care unit stays and increasing antibiotic demands, Ventilator-associated pneumonia usually negatively impacts the Prognosis of critically ill patients.
Central line-associated bloodstream infections are a source of morbidity and impose an important financial burden. As a public safety net health system, we continually strive to improve the quality of our care and to minimize cost. Every health care associated infection is scrutinized to assess whether it could have been prevented. To our surprise, one patient recently fulfilled the National Healthcare Safety Network surveillance definition for a Central line-associated bloodstream infections in a situation which could have been avoided if Probiotics were more carefully handled.
Urinary tract infection is a common bacterial infection that can lead to significant morbidity including stricture, abscess formation, fistula, bacteremia, sepsis, and pyelonephritis and kidney dysfunction. Mortality rates are reported to be as high as 1% in men and 3% in women due to development of pyelonephritis. Because probiotic therapy is readily available without a prescription, a review of their efficacy in the prevention of Urinary tract infection may aid consumers in making informed decisions about potential prophylactic therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Sugar tabletsThe (Control group) will receive placebo (sugar tablets) |
| Test group | Experimental | Biological: Bacillus clausiiThe (Test group) will receive bacillus clausii (Enterogermina) 4 billion every 12h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of both genders aged 18 years or older
- Critically ill patients (medical and surgical) with Acute Physiology and Chronic Health Evaluation II >=10
Key exclusion criteria (3 listed)
- Patients with active cancer/on chemotherapy and/or radiotherapy/autoimmune diseases/ immunomodulating drugs/ neutropenic fever.
- Pregnancy
- Relatives refuse to share in the study
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 |
|---|---|---|
| Bacillus clausiiThe (Test group) will receive bacillus clausii (Enterogermina) 4 billion every 12h. | Biological | Test group |
| Sugar tabletsThe (Control group) will receive placebo (sugar tablets). | Other | Control group |
Primary outcome
Occurrence of systemic infections
Time frame: one month
1 secondary outcome
ICU length of stay
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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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.
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 Bacillus clausii and Sugar tablets in people with Ventilator Acquired Pneumonia and Catheter Related Bloodstream Infection, run by Benha University at 1 site in Egypt.
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 2 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 10 Sep 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Occurrence of systemic infections (time frame: one month). 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 10 Sep 2025.