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RecruitingNCT06323642Updated Mar 21, 2024

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

An interventional study of probiotic containing Lactobacillus rhamnosus GG. and placebo in Pneumonia and Probiotics, sponsored by Shaheed Zulfiqar Ali Bhutto Medical University. Recruiting at 1 site in Pakistan. Open to participants aged 6 Months to 2 Years. Per ClinicalTrials.gov, last updated 2024-03-21.

Sponsored by Shaheed Zulfiqar Ali Bhutto Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
6 Months to 2 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pneumonia
  • Probiotics

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Keywords

  • pneumonia treatment
  • probiotics
03

Who can participate

Ages eligible
6 Months to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    A

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

    Dietary Supplement: probiotic containing Lactobacillus rhamnosus GG.

  • Placebo comparator
    B

    placebo mixture will be given to patients with pneumonia

    Other: placebo

Interventions

  • Dietary supplementprobiotic containing Lactobacillus rhamnosus GG.

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

  • Otherplacebo

    milk as placebo

05

What researchers measure

Primary outcomes

  1. Number of days in hospital

    hospital stay in patients admitted with severe pneumonia.

    Time frame: 6 month

Secondary outcomes

  1. Number of days with cough, fever

    Improving symptoms in patients admitted with severe pneumonia.

    Time frame: 6 month

06

Study locations

1 of 1 sites recruiting
  • Pakistan Institute of Medical Sciences
    Islamabad, Punjab 12000, Pakistan
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06323642
Lead sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
Responsible party
Dr Nighat Haider (assisstant professor, Shaheed Zulfiqar Ali Bhutto Medical University) — Principal investigator
First posted
Mar 21, 2024
Start date
Sep 1, 2023
Primary completion
Mar 31, 2024 (estimated)
Completion
Mar 31, 2024 (estimated)
Last update
Mar 21, 2024

Study contacts

Nighat Haider
Contact
nighathaider@hotmail.com
+923212125768
Rashiqa Saadat, MBBS
Contact
rashi.bs@hotmail.com
+923436568998
Nighat Haider
study chair · SZABMU

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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