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

March 20, 2024 updated by: Dr Nighat Haider, Shaheed Zulfiqar Ali Bhutto Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Islamabad, Punjab, Pakistan, 12000
        • Recruiting
        • Pakistan Institute of Medical Sciences
        • Contact:
        • Principal Investigator:
          • rashiqa saadat, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
probiotic mixture will be given daily to patients probiotic mixture containing: Lactobacillus rhamnosus GG
Dietary supplement: probiotic containing Lactobacillus rhamnosus GG.
probiotic containing Lactobacillus rhamnosus GG will be given daily for 3 days
Placebo Comparator: B
placebo mixture will be given to patients with pneumonia
Other: placebo
milk as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days in hospital
Time Frame: 6 month
hospital stay in patients admitted with severe pneumonia.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days with cough, fever
Time Frame: 6 month
Improving symptoms in patients admitted with severe pneumonia.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Investigators

  • Study Chair: Nighat Haider, SZABMU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F.1-1/20ERB/SZABMU/941

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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