NCT06323642

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 4, 2024

Last Update Submit

March 20, 2024

Conditions

PneumoniaProbiotics

Keywords

pneumonia treatmentprobiotics

Outcome Measures

Primary Outcomes (1)

  • Number of days in hospital

    hospital stay in patients admitted with severe pneumonia.

    6 month

Secondary Outcomes (1)

  • Number of days with cough, fever

    6 month

Study Arms (2)

A

EXPERIMENTAL

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

Dietary Supplement: probiotic containing Lactobacillus rhamnosus GG.

B

PLACEBO COMPARATOR

placebo mixture will be given to patients with pneumonia

Other: placebo

Interventions

probiotic containing Lactobacillus rhamnosus GG.DIETARY_SUPPLEMENT

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

A
placeboOTHER

milk as placebo

B

Eligibility Criteria

Age6 Months - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Institute of Medical Sciences

Islamabad, Punjab Province, 12000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nighat Haider

    SZABMU

    STUDY CHAIR

Central Study Contacts

Nighat Haider

CONTACT

+923212125768nighathaider@hotmail.com

Rashiqa Saadat, MBBS

CONTACT

+923436568998rashi.bs@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 21, 2024

Study Start

September 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)