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Probiotics tested as infection shield for ICU patients

NCT ID NCT07164781

Disease control Sponsor: Benha University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether giving probiotics (Bacillus clausii) to critically ill adults can reduce serious infections like pneumonia and bloodstream infections. One hundred ICU patients will receive either the probiotic or a sugar pill, and researchers will track infection rates and length of hospital stay. The goal is to see if a simple, safe supplement can help protect vulnerable patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bacillus clausii (a type of probiotic)
What this could lead to
If it works, this could point toward a simple, low-cost way to lower infection rates in intensive care patients.
What could go wrong
This is a small, early-stage trial with only 100 patients. Probiotics may not prevent infections, and results may not apply to all ICU patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * Patients with active cancer/on chemotherapy and/or radiotherapy/autoimmune diseases/ immunomodulating drugs/ neutropenic fever. * Pregnancy * Relatives refuse to share in the study

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Conditions

The condition(s) this trial relates to.

diarrheal disease Pneumonia, Ventilator-Associated Toxemia urinary tract infection infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Catheter-related bloodstream infection Diarrhea Probiotics Urinary tract infection Ventilator acquired pneumonia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Benha University Hospitals

    Banhā, Qalyubia Governorate, 13518, Egypt

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