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

Muhammad Aamir Latif

Status: Completed

Conditions: Acute Watery Diarrhea

Treatments: Drug: Probiotic Bacillus Clausii

Study type: Interventional

Funder types: Other

Identifiers

NCT06887374

AWD-CH-LAHORE

Details and patient eligibility

About

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

Full description

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.

Enrollment: 184 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 2 patient groups

Probiotic group

Experimental group

Description:

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.

Treatment:

Drug: Probiotic Bacillus Clausii

No probiotic group

No Intervention group

Description:

Patients received only standard treatment as per WHO guidelines.