The effect of the administration of bacterial live microorganisms with health benefits on the occurrence of lung infection in patients requiring machine assisted breathing.

The Effect of Probiotics on Ventilator Associated Pneumonia - A Randomized Controlled Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009348

Enrollment

280

Registered

2017-08-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Critically ill patients on mechanical ventilation Health Condition 2: J969- Respiratory failure, unspecified

Interventions

Intervention1: Probiotic: The probiotic used will be Pre-pro HS capsule which contains Lactobacillus acidophilus 700 million cells, Lactobacillus rhamnosus 400 million cells, Lactobacillus casei 300

Eligibility

Inclusion criteria

Inclusion criteria: 1. Mechanical ventilated patients of age > 18 years. 2. Perceived need for Ventilation more than 48 hours.

Exclusion criteria

Exclusion criteria: 1. Mechanical ventilation initiated outside JIPMER hospital 2. Prior Mechanical ventilation for > 24 hours 3. Pneumonia patients requiring Mechanical Ventilation 4. Neutropenic patients 5. Pregnancy and Lactation 6. APACHE II score more than 25 7. Patients with acute severe pancreatitis

Design outcomes

Primary

Measure	Time frame
Incidence of Ventilator Associated Pneumonia (VAP)Timepoint: Day 3 of Mechanical Ventilation to 48 hours after discontinuation of Mechanical Ventilation.	—

Secondary

Measure	Time frame
1. Time taken for the occurrence of VAP after mechanical ventilation is initiatedTimepoint: From the date of enrollment to 48 hours after discontinuation from Mechanical Ventilation.;2. Rate of Infectious complicationsTimepoint: From the date of enrollment to day of ICU discharge.;3. Antibiotic use (Rate/Number/Type)Timepoint: From the date of enrollment to day of ICU discharge.;4. Duration of VentilationTimepoint: From the date of enrollment to day of ICU discharge.;5. Length of ICU stayTimepoint: From the date of enrollment to day of ICU discharge.;6. 28 day Mortality after Mechanical VentilationTimepoint: From the date of enrollment to 28 days.	—

Measure

Time frame

1. Time taken for the occurrence of VAP after mechanical ventilation is initiatedTimepoint: From the date of enrollment to 48 hours after discontinuation from Mechanical Ventilation.;2. Rate of Infectious complicationsTimepoint: From the date of enrollment to day of ICU discharge.;3. Antibiotic use (Rate/Number/Type)Timepoint: From the date of enrollment to day of ICU discharge.;4. Duration of VentilationTimepoint: From the date of enrollment to day of ICU discharge.;5. Length of ICU stayTimepoint: From the date of enrollment to day of ICU discharge.;6. 28 day Mortality after Mechanical VentilationTimepoint: From the date of enrollment to 28 days.

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Countries

India

Contacts

Public ContactVenkateswaran R

JIPMER, Puducherry

drvenks@gmail.com9488505555

Outcome results

None listed

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