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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06887374

Enrollment

184

Registered

2025-03-20

Start date

2024-03-01

Completion date

2024-09-30

Last updated

2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Watery Diarrhea

Brief summary

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

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.

Interventions

DRUGProbiotic Bacillus Clausii

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Months to 59 Months

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

Design outcomes

Primary

Measure	Time frame	Description
Stool frequency	5 days	A frequency of defecation of \< 3 stools per day marked the effectiveness of the treatment.
Consistency of stools	5 days	The treatment was considered effective if the consistency of stools became semi-solid.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026