Acute Watery DiarrheaNCT06540209
Comparison of Effectiveness of Zinc Supplementation With ORS and Bacillus Clausii Versus Zinc With ORS and Saccharomyces Boulardii in Acute Watery Diarrhea in Paediatric Patients
A study testing Bacillus clausii, Saccharomyces boulardii and Zinc in people with Acute Watery Diarrhea, run by RESnTEC, Institute of Research at 1 site in Pakistan.
Trial summary
The current study was carried out to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii among the local pediatric population presenting with acute watery diarrhea. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Acute Watery Diarrhea
- What is being tested?
- Bacillus clausii, Saccharomyces boulardii and Zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 30 Sep 2023
- 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 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients of either gender
- Aged 3 months to 5 years
- With acute watery diarrhea last less fewer than 14 days
- Presenting with mild to moderate dehydration
Who cannot join
- Patients with a history of blood or pus in their stools
- History of recent antibiotic or probiotic treatment
- Patients with immunodeficiency conditions, acute systemic illnesses, or chronic diarrhea
- Patients with hypersensitivity to Bacillus clausii or Saccharomyces boulardii
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Child Health Sciences, The Children's Hospital
Lahore, Punjab Province, 54000
About this study
The current study was carried out to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii among the local pediatric population presenting with acute watery diarrhea.
Read the detailed description
The results and importance of effective treatment for acute watery diarrhea in pediatric patients vary throughout the world. Previously, very limited literature was available comparing the efficacy of Bacillus clausii and Saccharomyces boulardii in acute watery diarrhea, providing mixed results. The current study aims to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii.
- Conditions
- Acute Watery Diarrhea
- Being tested
- Bacillus clausii, Saccharomyces boulardii, Zinc, ORS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus clausiiDrug
Also called Probiotics
Children will be give Bacillus clausii for 5 days
Saccharomyces boulardiiDrug
Also called Probiotics
Children will be give Saccharomyces boulardii for 5 days
ZincDrug
Also called Standard treatment
Zinc will be given to all children for 5 days
ORSDrug
Also called Standard treatment
ORS will be given to all children for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Bacillus clausii + zinc+ ORS group | Experimental | Patients received zinc supplementation with ORS and Bacillus clausii Receives: Drug: Bacillus clausii; Drug: Zinc; Drug: ORS |
| Saccharomyces boulardii +zinc+ ORS group | Experimental | Patients were given zinc with ORS and Saccharomyces boulardii Receives: Drug: Saccharomyces boulardii; Drug: Zinc; Drug: ORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency
Number of stools per day
Measured: 5 days
Stool consistency
Graded on a five-point scale as firm, soft, thick liquid, opaque watery, and watery
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Apr 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- RESnTEC, Institute of Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajiha Rizwan, FCPS, Principal investigator, University of Child Health Sciences, The Children's Hospital Lahore, PakistanMuhammad Tufail, MBBS, Principal investigator, University of Child Health Sciences, The Children's Hospital Lahore, PakistanAzher Abbas Shah, Principal investigator, University of Child Health Sciences, The Children's Hospital Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540209
- Sponsor's protocol ID
- AWD-CHLAHORE
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared with other researchers on a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Zinc Supplementation With ORS and Bacillus Clausii Versus Zinc With ORS and Saccharomyces Boulardii in Acute Watery Diarrhea in Paediatric Patients
- ClinicalTrials.gov ID
- NCT06540209
- Acronym / sponsor ID
- AWD-CHLAHORE
- Conditions
- Acute Watery Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- RESnTEC, Institute of ResearchUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 6 Aug 2024 (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.
The current study was carried out to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii among the local pediatric population presenting with acute watery diarrhea.
Detailed description
The results and importance of effective treatment for acute watery diarrhea in pediatric patients vary throughout the world. Previously, very limited literature was available comparing the efficacy of Bacillus clausii and Saccharomyces boulardii in acute watery diarrhea, providing mixed results. The current study aims to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacillus clausii + zinc+ ORS group | Experimental | Drug: Bacillus clausii, Drug: Zinc, Drug: ORSPatients received zinc supplementation with ORS and Bacillus clausii |
| Saccharomyces boulardii +zinc+ ORS group | Experimental | Drug: Saccharomyces boulardii, Drug: Zinc, Drug: ORSPatients were given zinc with ORS and Saccharomyces boulardii |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients of either gender
- Aged 3 months to 5 years
- With acute watery diarrhea last less fewer than 14 days
- Presenting with mild to moderate dehydration
Key exclusion criteria (4 listed)
- Patients with a history of blood or pus in their stools
- History of recent antibiotic or probiotic treatment
- Patients with immunodeficiency conditions, acute systemic illnesses, or chronic diarrhea
- Patients with hypersensitivity to Bacillus clausii or Saccharomyces boulardii
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 |
|---|---|---|
| Bacillus clausiiAlso: ProbioticsChildren will be give Bacillus clausii for 5 days | Drug | Bacillus clausii + zinc+ ORS group |
| Saccharomyces boulardiiAlso: ProbioticsChildren will be give Saccharomyces boulardii for 5 days | Drug | Saccharomyces boulardii +zinc+ ORS group |
| ZincAlso: Standard treatmentZinc will be given to all children for 5 days | Drug | Bacillus clausii + zinc+ ORS group, Saccharomyces boulardii +zinc+ ORS group |
| ORSAlso: Standard treatmentORS will be given to all children for 5 days | Drug | Bacillus clausii + zinc+ ORS group, Saccharomyces boulardii +zinc+ ORS group |
Primary outcome
Stool frequency
Time frame: 5 days
Number of stools per day
Stool consistency
Time frame: 5 days
Graded on a five-point scale as firm, soft, thick liquid, opaque watery, and watery
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 12 Aug 2024.
- Individual participant dataSharing planned: No. Data can be shared with other researchers 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.
Wajiha Rizwan, FCPS principal investigator
University of Child Health Sciences, The Children's Hospital Lahore, Pakistan
Muhammad Tufail, MBBS principal investigator
University of Child Health Sciences, The Children's Hospital Lahore, Pakistan
Azher Abbas Shah principal investigator
University of Child Health Sciences, The Children's Hospital Lahore, 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 Bacillus clausii, Saccharomyces boulardii and Zinc in people with Acute Watery Diarrhea, run by RESnTEC, Institute of Research 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 4 inclusion and 4 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 12 Aug 2024. 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?
Stool frequency (time frame: 5 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 12 Aug 2024.