Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe Pneumonia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Number of days in hospital
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo
Eligibility Criteria
- Ages
- 6 Months to 2 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
probiotic mixture will be given daily to patients probiotic mixture containing: Lactobacillus rhamnosus GG
Intervention: probiotic containing Lactobacillus rhamnosus GG. (Dietary Supplement)
B
placebo mixture will be given to patients with pneumonia
Intervention: placebo (Other)
Outcomes
Primary Outcomes
Number of days in hospital
Time Frame: 6 month
hospital stay in patients admitted with severe pneumonia.
Secondary Outcomes
- Number of days with cough, fever(6 month)
Investigators
Dr Nighat Haider
assisstant professor
Shaheed Zulfiqar Ali Bhutto Medical University
