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Completed

NCT Number: NCT07168304

Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in the Treatment of Acute Diarrhea

In literature combined therapy of zinc with S. boulardii in the treatment of acute diarrhea has not been addressed satisfactorily in the recent past. Therefore, this study was planned aiming to compare the mean time taken to resolve diarrhea and the mean time taken to resolve vomiting in children under 5 years of age having acute diarrhea with zinc plus S. boulardii versus zinc alone.

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Key information

Conditions

Acute Watery Diarrhea

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital and The Institute of Child Health

Multan, Punjab Province, 66000, Pakistan

About this study

Zinc has been used as a recommended choice treating acute watery ailments among children. If any significant beneficial effect in the combined efficacy of zinc with S. boulardii is found, it may add on to pre-existing knowledge and may lead clinicians to delineate the treatment guidelines to provide more effective treatment to the patients in clinical practices to reduce undesirable morbidity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children of either gender
  • Aged between 1 month up to 5 years
  • Presented with acute diarrhea

Exclusion criteria

  • Children with concurrent acute illnesses (meningitis, sepsis, or pneumonia)
  • Severe chronic conditions (cystic fibrosis, endocrinopathies, food allergies, or chronic gastrointestinal diseases)
  • Severe undernutrition (weight-for-age <60% of the 50th percentile of CDC 2000 standards)
  • Children who used probiotics, antibiotics, or anti-diarrheal drugs within the past 7 days
  • The presence of visible blood in stools

Treatment and study plan

S. boulardii

Drug

Participants received zinc plus S. boulardii supplementation according to the World Health Organization recommendations.

Primary outcomes

  1. Resolution of diarrhea

    Time frame: 7 days

    The duration from initiation of treatment until passage of normal stools (Bristol Stool Form Scale types 3-4).

  2. Resolution of vomiting

    Time frame: 14 hours

    The time from the start of treatment to the last episode of vomiting.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

Clinical Outcome of Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in the Treatment of Acute Diarrhea in Children Under 5 Years of Age

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 11, 2025
Registry last updated
Sep 11, 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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