Skip to content

Synbiotics Prophylaxis to Prevent Ventilator-associated Pneumonia

Synbiotics Prophylaxis to Prevent Ventilator-associated Pneumonia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130917014693N18
Enrollment
80
Registered
2025-07-23
Start date
2025-07-23
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator-Associated Pneumonia (VAP). Pneumonia, unspecified organism

Interventions

Intervention 1: Patients in this group receive Femilact® tablets (manufactured by Zist Takhmir Co.) twice daily. Each tablet contains 10? CFU of probiotics (Lactobacillus rhamnosus, Bifidobacterium la

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients aged 18 years or older Patients undergoing mechanical ventilation No prior administration of antibiotics effective against common VAP-associated strains Non-pregnant and non-lactating patients Absence of underlying chronic pulmonary diseases such as asthma or COPD Absence of immunocompromising conditions or immunosuppressive therapy; patients not undergoing hemodialysis No known history of hypersensitivity to any components of the synbiotic FamiLact®

Exclusion criteria

Exclusion criteria: Patient or family unwillingness to continue participation in the study Transfer to another healthcare facility or discharge from the ICU within less than 5 days Inability to receive the probiotic within the first 48 hours of intubation, regardless of cause History of gastrectomy, esophagectomy, pancreatectomy, gastric bypass, gastric banding, or short bowel syndrome Administration of broad-spectrum antibiotics or diagnosis of infections due to causes other than ventilator-associated pneumonia (VAP)

Design outcomes

Primary

MeasureTime frame
Temperature. Timepoint: Duraing the study. Method of measurement: Thermometer.;Pulmonary secretions. Timepoint: During the study. Method of measurement: Chest buttle, Observation by an intensive care unit nurse.;White blood cell. Timepoint: During the study. Method of measurement: Laboratory.

Secondary

MeasureTime frame
Number of days of hospitalisation. Timepoint: The first and last day of the study. Method of measurement: Medical record.;Blood creatinine level. Timepoint: During the study. Method of measurement: Laboratory.;Blood culture. Timepoint: During the study. Method of measurement: Laboratory.;Blood Urea Nitrogen. Timepoint: During the study. Method of measurement: Laboratory.;Arterial blood gas test. Timepoint: During the study. Method of measurement: Measurement using arterial blood sampling and a blood gas analyser.;Bilirubin. Timepoint: During the study. Method of measurement: Laboratory.;Lactate. Timepoint: During the study. Method of measurement: Laboratory.;Alanine Aminotransferase. Timepoint: During the study. Method of measurement: Laboratory.;Aspartate Aminotransferase. Timepoint: During the study. Method of measurement: Laboratory.;Heart Rate. Timepoint: During the study. Method of measurement: Assessment through electrocardiographic (ECG) monitoring.;Creatinine Clearance. Timepoint: During the study. Method of measurement: Calculation using standard creatinine clearance formula and measurement of serum creatinine level in the laboratory.;Blood pressure. Timepoint: During the study. Method of measurement: Digital blood pressure monitor.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Sahraei

Shahid Beheshti University of Medical Sciences

z.sahraei@sbmu.ac.ir+98 21 8820 0118

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026