Comparison of WHO Treatment of Acute Watery Diarrhea With or Without Probiotic (Bacillus Clausii) in Children

NCT ID: NCT06887374

Last Updated: 2025-03-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-09-30

Brief Summary

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This study aimed to compare WHO treatment of acute watery diarrhea with or without probiotic (bacillus clausii) in term of mean duration of diarrhea in children

Detailed Description

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Available literature regarding the use of probiotics is not conclusive and contains controversy, and local data is also scarce. Therefore, this study was planned to further explore the use of probiotics to furnish the local data. If significantly less mean duration of diarrhea is noted in the probiotic group, it will help to add probiotic bacillus clausii in routine treatment regimen recommended by WHO and to decrease costs associated with prolonged treatment. However, if otherwise results will be noted it will help to rule out use of probiotic bacillus clausii in children with acute diarrhea to avoid its unnecessary use.

Conditions

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Acute Watery Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Probiotic group

Patients received 2 billion spores of probiotic (Bacillus clausii) every 12 hours, contained in a small bottle along with standard treatment as per WHO guidelines.

Group Type EXPERIMENTAL

Probiotic Bacillus Clausii

Intervention Type DRUG

Patients were given 2 billion spores of probiotic (Bacillus clausii) every12 hours, contained in a small bottle.

No probiotic group

Patients received only standard treatment as per WHO guidelines.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Probiotic Bacillus Clausii

Patients were given 2 billion spores of probiotic (Bacillus clausii) every12 hours, contained in a small bottle.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Both genders
* Aged 6 to 59 months
* Suffering from acute watery diarrhea for ≤ 7 days

Exclusion Criteria

* Children with blood in stool
* With prior antibiotics use
* Children under study with duration of stay more than 5 days
* clinical signs of a coexisting acute systemic illness like pneumonia, sepsis, meningitis, severely malnourished
* Immunocompromised children
* Hypersensitivity to probiotics
* With prior probiotic administration
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muhammad Aamir Latif

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Aamir Latif

Research Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Talha Hassan

Role: PRINCIPAL_INVESTIGATOR

Children Hospital, Lahore, Pakistan

Muhammad Zeeshan

Role: STUDY_DIRECTOR

Children Hospital, Lahore, Pakistan

Locations

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Children Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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AWD-CH-LAHORE

Identifier Type: -

Identifier Source: org_study_id

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