Clinical Outcome of Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in the Treatment of Acute Diarrhea in Children Under 5 Years of Age
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 276
- Locations
- 1
- Primary Endpoint
- Resolution of vomiting
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Probiotic group
Standard treatment plus S. boulardii
Intervention: S. boulardii (Drug)
Outcomes
Primary Outcomes
Resolution of vomiting
Time Frame: 14 hours
The time from the start of treatment to the last episode of vomiting.
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research