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Efficacy and safety of three treatment methods with probiotics, domperidone and their combination compared to the control group in preventing VAP in severe brain trauma patients hospitalized in intensive care units

Investigating the effectiveness and safety of three treatment methods with probiotics, domperidone and their combination compared to the control group in preventing VAP in severe brain trauma patients admitted to the special care units of Shahid Rahmonun Hospital in Yazd

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190810044500N28
Enrollment
120
Registered
2024-10-08
Start date
2024-10-22
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Ventilator-Associated Pneumonia. Unspecified acute lower respiratory infection

Interventions

Intervention 1: Intervention group: In the first group, patients will receive one Femilact (Zist-Takhmir Com.) capsule and one placebo tablet (prepared by pharmaceutics laboratory of Yazd Faculty of P

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with head trauma and older than 18 years who have been mechanically ventilated for at least 48 hours Oxygen saturation (O2 saturation) greater than 90% FIO2 less than 50% PEEP less than 8 cm of water Hemodynamic stability during the last 12 hours Body temperature between 36 and 39 degrees

Exclusion criteria

Exclusion criteria: Patients who do not agree to participate in the study Severe immune system defects (acquired or genetic) including patients with active cancer undergoing chemotherapy or active HIV Fever before endotracheal intubation Patients who underwent cardiopulmonary resuscitation after trauma Patients with a history of previous sensitivity to domperidone and probiotic compounds Taking other probiotic drugs Patients with gastrointestinal absorption intolerance Patients with previous tracheostomy or history of mechanical ventilation in the same hospital

Design outcomes

Primary

MeasureTime frame
Blood gases including oxygen pressure, carbon dioxide, saturated oxygen pressure and pH. Timepoint: Before starting the intervention and one day later and after weaning of mechanical ventilation. Method of measurement: blood sample.;Hemoglobin. Timepoint: Before starting the intervention and one day later and after weaning of mechanical ventilation. Method of measurement: blood sample.;Level of consciousness. Timepoint: Before starting the intervention and one day later and after weaning of mechanical ventilation. Method of measurement: glass coma scale.;Sofa score. Timepoint: Before starting the intervention and one day later and after weaning of mechanical ventilation. Method of measurement: Scoring based on pulmonary, coagulation, liver, cardiovascular, central nervous system and kidney status.

Secondary

MeasureTime frame
The duration of weaning. Timepoint: From the start of the process of separation from the device until the patient's spontaneous breathing. Method of measurement: Counting the number of days.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Saghafi

Yazd University of Medical Sciences

F.saghafi@ssu.ac.ir+98 35 3820 3419

Outcome results

None listed

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