Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe Pneumonia

Not Applicable

Recruiting

• Conditions: Probiotics; Pneumonia
• Interventions: Dietary Supplement: probiotic containing Lactobacillus rhamnosus GG.; Other: placebo

• Registration Number: NCT06323642
• Lead Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

Brief Summary

Probiotics as adjuvant therapy along with standard care can decrease hospital stay and improve symptoms (fever, tachypnea,cough) in pediatric patients admitted with severe pneumonia.

Detailed Description

After getting written informed consent from parents/attendants, all patients aged 6 month-2yrs admitted with severe pneumonia in pediatric wards of children hospital, during the study time of 6 month will be recruited.After applying exclusion criteria remaining participants will be included in the study. The study population will be randomized in to two groups, Group A will be given probiotic sachet and group B will be given simple milk as placebo.The patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo The probiotic and placebo mixture will be given daily for three days.The patients in both the groups will be followed for the duration of illness until they are either discharged or show any adverse outcomes of pneumonia.Total days of admission will be recoded for patients discharged from hospital.Parents will be asked questions regarding improvement in symptoms like fever on discharge. Duration for Improvement in tachypnea andcough will be noted for all patients. Outcomes will be duration of hospital admission, improvement in fever, tachypnea and cough.All the data collected will be entered and analyzed using SPSS latest version and analysed.

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Patients with severe acute malnutrition Patients with very severe pneumonia Patients with Other concurrent infections Patients having any chronic debilitating condition Children who took probiotics in past 6 months Patient requiring mechanical ventilation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	probiotic containing Lactobacillus rhamnosus GG.	probiotic mixture will be given daily to patients probiotic mixture containing: Lactobacillus rhamnosus GG
B	placebo	placebo mixture will be given to patients with pneumonia

Primary Outcome Measures

Name	Time	Method
Number of days in hospital	6 month	hospital stay in patients admitted with severe pneumonia.

Secondary Outcome Measures

Name	Time	Method
Number of days with cough, fever	6 month	Improving symptoms in patients admitted with severe pneumonia.

Trial Locations

Locations (1)

Pakistan Institute of Medical Sciences; 🇵🇰 Islamabad, Punjab, Pakistan