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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07168304

Enrollment

276

Registered

2025-09-11

Start date

2025-02-01

Completion date

2025-07-31

Last updated

2025-09-11

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

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.

Detailed description

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.

Interventions

DRUGS. boulardii

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 5 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Resolution of diarrhea	7 days	The duration from initiation of treatment until passage of normal stools (Bristol Stool Form Scale types 3-4).
Resolution of vomiting	14 hours	The time from the start of treatment to the last episode of vomiting.

Countries

Pakistan

Outcome results

None listed

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