Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in th... | NCT07168304

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

NCT07168304

Sponsor

Muhammad Aamir Latif

Status

Completed

Last Update Posted

Sep 11, 2025Actual

Enrollment

276Actual

Phase

Not Applicable

Conditions

Acute Watery Diarrhea

Interventions

S. boulardii

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2025Actual

Primary Completion Date

Jul 31, 2025Actual

Completion Date

Jul 31, 2025Actual

First Submitted Date

Sep 4, 2025

First Submission Date that Met QC Criteria

Sep 4, 2025

First Posted Date

Sep 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2025

Last Update Posted Date

Sep 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

276Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic group	Experimental	Standard treatment plus S. boulardii	Drug: S. boulardii
No probiotic group	No Intervention	Standard treatment only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S. boulardii	Drug	Participants received zinc plus S. boulardii supplementation according to the World Health Organization recommendations.	Probiotic group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Muhammad Hammad Riaz	Children's Hospital and institute of Child Health Multan, Punjab, Pakistan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Children's Hospital and The Institute of Child Health		Multan	Punjab Province	66000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Data can be shared on a reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided