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

S

Shaheed Zulfiqar Ali Bhutto Medical University

Status

Enrolling

Conditions

Pneumonia
Probiotics

Treatments

Other: placebo
Dietary Supplement: probiotic containing Lactobacillus rhamnosus GG.

Study type

Interventional

Funder types

Other

Identifiers

NCT06323642
F.1-1/20ERB/SZABMU/941

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

6 months to 2 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups, including a placebo group

A
Experimental group
Description:
probiotic mixture will be given daily to patients probiotic mixture containing: Lactobacillus rhamnosus GG
Treatment:
Dietary Supplement: probiotic containing Lactobacillus rhamnosus GG.
B
Placebo Comparator group
Description:
placebo mixture will be given to patients with pneumonia
Treatment:
Other: placebo

Trial contacts and locations

1

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Central trial contact

Nighat Haider; Rashiqa Saadat, MBBS

Data sourced from clinicaltrials.gov

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