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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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
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.

Egypt1 site
  • Benha University Hospitals

    Banhā, Qalyubia Governorate, 13518

Other trials in Egypt

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.

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 groups in NCT07164781
Study groupRoleWhat they receive
Control groupPlacebo comparatorThe (Control group) will receive placebo (sugar tablets)
Receives: Other: Sugar tablets
Test groupExperimentalThe (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.

  1. Occurrence of systemic infections

    Measured: one month

Secondary outcomes (1)
  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.

  1. First posted10 Sep 2025
  2. Study start1 Apr 2025
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion2 Dec 2025 (estimated)

Resources

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)
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

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.

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