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

NCT07164781 | Enrolling By Invitation

• 1 other identifier: MD 10-4-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Probiotic; Systemic infection

Outcome Measures

Primary Outcomes (1)

• Occurrence of systemic infections

  one month

Secondary Outcomes (1)

• ICU length of stay

  one month

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Other: Sugar tablets

Test group

EXPERIMENTAL

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

Biological: Bacillus clausii

Interventions

Bacillus clausii BIOLOGICAL

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

Test group

Sugar tablets OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospitals

Banhā, Qalyubia Governorate, 13518, Egypt

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Urinary Tract Infections; Diarrhea; Toxemia

Interventions

clausin peptide, Bacillus clausii; Sugars

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: September 10, 2025
• Study Start: April 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 2, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)