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NCT Number: NCT06887374

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

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

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Key information

Conditions

Acute Watery Diarrhea

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Bacillus Clausii

Drug

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

Primary outcomes

  1. Stool frequency

    Time frame: 5 days

    A frequency of defecation of < 3 stools per day marked the effectiveness of the treatment.

  2. Consistency of stools

    Time frame: 5 days

    The treatment was considered effective if the consistency of stools became semi-solid.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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