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

NCT07168304 | Completed

• 1 other identifier: Dr-Hammad-Multan
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Watery Diarrhea

Outcome Measures

Primary Outcomes (2)

• Resolution of diarrhea

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

  7 days

• Resolution of vomiting

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

  14 hours

Study Arms (2)

Probiotic group

EXPERIMENTAL

Standard treatment plus S. boulardii

Drug: S. boulardii

No probiotic group

NO INTERVENTION

Standard treatment only

Interventions

S. boulardii DRUG

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

Probiotic group

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

The Children's Hospital and The Institute of Child Health

Multan, Punjab Province, 66000, Pakistan

Location

Study Officials

• Muhammad Hammad Riaz

  Children's Hospital and institute of Child Health Multan, Punjab, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: February 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)