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NCT06323642 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06323642
Other study ID # F.1-1/20ERB/SZABMU/941
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date March 31, 2024

Study information
Verified date March 2024
Source Shaheed Zulfiqar Ali Bhutto Medical University
Contact Nighat Haider
Phone +923212125768
Email nighathaider@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Months to 2 Years
Eligibility Inclusion criteria Patient aged 2month-24months. Both male and female children 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• probiotic containing Lactobacillus rhamnosus GG.
probiotic containing Lactobacillus rhamnosus GG will be given daily for 3 days
Other:
• placebo
milk as placebo

Locations
Country Name City State
Pakistan Pakistan Institute of Medical Sciences Islamabad Punjab

Sponsors (1)
Lead Sponsor Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of days in hospital hospital stay in patients admitted with severe pneumonia. 6 month
Secondary Number of days with cough, fever Improving symptoms in patients admitted with severe pneumonia. 6 month
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