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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acute Watery Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Probiotic group

Standard treatment plus S. boulardii

Group Type EXPERIMENTAL

S. boulardii

Intervention Type DRUG

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

No probiotic group

Standard treatment only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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S. boulardii

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No