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Enrolling by invitationNCT07164781Updated Sep 10, 2025

Effect of Use of Probiotics on Systemic Infection in Critically Ill Patients: a Double Blind, Randomized, Placebo-controlled Trial

An interventional study of Bacillus clausii and Sugar tablets in Ventilator Acquired Pneumonia, Catheter Related Bloodstream Infection and Urinary Tract Infection, sponsored by Benha University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Benha University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ventilator Acquired Pneumonia
  • Catheter Related Bloodstream Infection
  • Urinary Tract Infection
  • Diarrhea
  • Probiotics

Keywords

  • Probiotic
  • Systemic infection
03

In context

Pneumonia, Ventilator-Associated

420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.

This study's planned enrollment of 100 is below the median of 115 across 276 interventional studies indexed under Pneumonia, Ventilator-Associated.

Browse Pneumonia, Ventilator-Associated studies →

Lead sponsor

Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients of both genders aged 18 years or older
  • Critically ill patients (medical and surgical) with Acute Physiology and Chronic Health Evaluation II >=10

Exclusion criteria

Exclusion Criteria:

  • Patients with active cancer/on chemotherapy and/or radiotherapy/ diseases/ immunomodulating drugs/ neutropenic fever.
  • Pregnancy
  • Relatives refuse to share in the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Placebo comparator
    Control group

    The (Control group) will receive placebo (sugar tablets)

    Other: Sugar tablets

  • Experimental
    Test group

    The (Test group) will receive bacillus clausii (Enterogermina) 4 billion every 12h.

    Biological: Bacillus clausii

Interventions

  • The (Test group) will receive bacillus clausii (Enterogermina) 4 billion every 12h.

  • OtherSugar tablets

    The (Control group) will receive placebo (sugar tablets).

06

What researchers measure

Primary outcomes

  1. Occurrence of systemic infections

    Time frame: one month

Secondary outcomes

  1. ICU length of stay

    Time frame: one month

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Sep 2025, 5 months after the start.

Of 81 non-industry interventional studies with no phase under Pneumonia, Ventilator-Associated, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 5 months is below that.

Counting every sponsor, half of 82 studies reached it within 20 months; a quarter within 10 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
May 24, 2025
First posted
Sep 10, 2025
StartActual
Apr 1, 2025
Primary completionEst.
Sep 1, 2025
CompletionEst.
Dec 2, 2025
Last update
Sep 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07164781
Lead sponsor
Benha University
Responsible party
Doaa kamal Ahmed Ibrahim Qutb (Assistant lecturer, Benha University) — Principal investigator
First posted
Sep 10, 2025
Start date
Apr 1, 2025
Primary completion
Sep 1, 2025 (estimated)
Completion
Dec 2, 2025 (estimated)
Last update
Sep 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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Studies of the drug tested here: Bacillus clausii

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