Acute Watery DiarrheaNCT07168304
Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in the Treatment of Acute Diarrhea
A study testing S. boulardii in people with Acute Watery Diarrhea, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Acute Watery Diarrhea
- What is being tested?
- S. boulardii
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of either gender
- Aged between 1 month up to 5 years
- Presented with acute diarrhea
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The Children's Hospital and The Institute of Child Health
Multan, Punjab Province, 66000
About this study
Official title: Clinical Outcome of Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in the Treatment of Acute Diarrhea in Children Under 5 Years of Age
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.
Read the 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.
- Conditions
- Acute Watery Diarrhea
- Being tested
- S. boulardii
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S. boulardiiDrug
Participants received zinc plus S. boulardii supplementation according to the World Health Organization recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Standard treatment plus S. boulardii Receives: Drug: S. boulardii |
| No probiotic group | No intervention | Standard treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of diarrhea
The duration from initiation of treatment until passage of normal stools (Bristol Stool Form Scale types 3-4).
Measured: 7 days
Resolution of vomiting
The time from the start of treatment to the last episode of vomiting.
Measured: 14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Feb 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Watery DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Muhammad Hammad Riaz, Principal investigator, Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168304
- Sponsor's protocol ID
- Dr-Hammad-Multan
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Zinc Plus Saccharomyces Boulardii Versus Zinc Alone in the Treatment of Acute Diarrhea in Children Under 5 Years of Age
- ClinicalTrials.gov ID
- NCT07168304
- Acronym / sponsor ID
- Dr-Hammad-Multan
- Conditions
- Acute Watery Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Drug: S. boulardiiStandard treatment plus S. boulardii |
| No probiotic group | No intervention | –Standard treatment only |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children of either gender
- Aged between 1 month up to 5 years
- Presented with acute diarrhea
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S. boulardiiParticipants received zinc plus S. boulardii supplementation according to the World Health Organization recommendations. | Drug | Probiotic group |
Primary outcome
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).
Resolution of vomiting
Time frame: 14 hours
The time from the start of treatment to the last episode of vomiting.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Acute Watery Diarrhea
Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
Acute Watery Diarrhea, Acute Watery Diarrhoea
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Recruiting
Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children
Acute Watery Diarrhea
Active, not recruiting
Comparison of Bacillus Clausii and Saccharomyces Boulardii for Acute Diarrhea at Day 3
Acute Watery Diarrhea
Active, not recruiting
Comparison of Low Osmolar ORS and ReSoMal for Treating Acute Watery Diarrhea in Severely Malnourished Children Aged 6 Months to 5 Years
Acute Watery Diarrhea, Severe Acute Malnutrition in Childhood
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Hammad Riaz principal investigator
Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S. boulardii in people with Acute Watery Diarrhea, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of diarrhea (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.