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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pneumonia Probiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized control trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo

Study Groups

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A

probiotic mixture will be given daily to patients probiotic mixture containing: Lactobacillus rhamnosus GG

Group Type EXPERIMENTAL

probiotic containing Lactobacillus rhamnosus GG.

Intervention Type DIETARY_SUPPLEMENT

probiotic containing Lactobacillus rhamnosus GG will be given daily for 3 days

B

placebo mixture will be given to patients with pneumonia

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

milk as placebo

Interventions

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probiotic containing Lactobacillus rhamnosus GG.

probiotic containing Lactobacillus rhamnosus GG will be given daily for 3 days

Intervention Type DIETARY_SUPPLEMENT

placebo

milk as placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No