Acute Watery DiarrheaNCT06887374
Comparison of WHO Treatment of Acute Watery Diarrhea With or Without Probiotic (Bacillus Clausii) in Children
A study testing Probiotic Bacillus Clausii in people with Acute Watery Diarrhea, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
This study aimed to compare WHO treatment of acute watery diarrhea with or without probiotic (bacillus clausii) in term of mean duration of diarrhea in children Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Acute Watery Diarrhea
- What is being tested?
- Probiotic Bacillus Clausii
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 30 Sep 2024
- 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both genders
- Aged 6 to 59 months
- Suffering from acute watery diarrhea for ≤ 7 days
Who cannot join
- Children with blood in stool
- With prior antibiotics use
- Children under study with duration of stay more than 5 days
- clinical signs of a coexisting acute systemic illness like pneumonia, sepsis, meningitis, severely malnourished
- Immunocompromised children
- Hypersensitivity to probiotics
- With prior probiotic administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of WHO Treatment of Acute Watery Diarrhea With or Without Probiotic (Bacillus Clausii) in Term of Mean Duration of Diarrhea in Children
This study aimed to compare WHO treatment of acute watery diarrhea with or without probiotic (bacillus clausii) in term of mean duration of diarrhea in children
Read the detailed description
Available literature regarding the use of probiotics is not conclusive and contains controversy, and local data is also scarce. Therefore, this study was planned to further explore the use of probiotics to furnish the local data. If significantly less mean duration of diarrhea is noted in the probiotic group, it will help to add probiotic bacillus clausii in routine treatment regimen recommended by WHO and to decrease costs associated with prolonged treatment. However, if otherwise results will be noted it will help to rule out use of probiotic bacillus clausii in children with acute diarrhea to avoid its unnecessary use.
- Conditions
- Acute Watery Diarrhea
- Being tested
- Probiotic Bacillus Clausii
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Bacillus ClausiiDrug
Patients were given 2 billion spores of probiotic (Bacillus clausii) every12 hours, contained in a small bottle.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Patients received 2 billion spores of probiotic (Bacillus clausii) every 12 hours, contained in a small bottle along with standard treatment as per WHO guidelines. Receives: Drug: Probiotic Bacillus Clausii |
| No probiotic group | No intervention | Patients received only standard treatment as per WHO guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency
A frequency of defecation of < 3 stools per day marked the effectiveness of the treatment.
Measured: 5 days
Consistency of stools
The treatment was considered effective if the consistency of stools became semi-solid.
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 posted20 Mar 2025
- Study start1 Mar 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 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
- Talha Hassan, Principal investigator, Children Hospital, Lahore, PakistanMuhammad Zeeshan, Study director, Children Hospital, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887374
- Sponsor's protocol ID
- AWD-CH-LAHORE
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2025
- Last updated
- 20 Mar 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of WHO Treatment of Acute Watery Diarrhea With or Without Probiotic (Bacillus Clausii) in Term of Mean Duration of Diarrhea in Children
- ClinicalTrials.gov ID
- NCT06887374
- Acronym / sponsor ID
- AWD-CH-LAHORE
- Conditions
- Acute Watery Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 20 Mar 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.
This study aimed to compare WHO treatment of acute watery diarrhea with or without probiotic (bacillus clausii) in term of mean duration of diarrhea in children
Detailed description
Available literature regarding the use of probiotics is not conclusive and contains controversy, and local data is also scarce. Therefore, this study was planned to further explore the use of probiotics to furnish the local data. If significantly less mean duration of diarrhea is noted in the probiotic group, it will help to add probiotic bacillus clausii in routine treatment regimen recommended by WHO and to decrease costs associated with prolonged treatment. However, if otherwise results will be noted it will help to rule out use of probiotic bacillus clausii in children with acute diarrhea to avoid its unnecessary use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Drug: Probiotic Bacillus ClausiiPatients received 2 billion spores of probiotic (Bacillus clausii) every 12 hours, contained in a small bottle along with standard treatment as per WHO guidelines. |
| No probiotic group | No intervention | –Patients received only standard treatment as per WHO guidelines. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Both genders
- Aged 6 to 59 months
- Suffering from acute watery diarrhea for ≤ 7 days
Key exclusion criteria (7 listed)
- Children with blood in stool
- With prior antibiotics use
- Children under study with duration of stay more than 5 days
- clinical signs of a coexisting acute systemic illness like pneumonia, sepsis, meningitis, severely malnourished
- Immunocompromised children
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 |
|---|---|---|
| Probiotic Bacillus ClausiiPatients were given 2 billion spores of probiotic (Bacillus clausii) every12 hours, contained in a small bottle. | Drug | Probiotic group |
Primary outcome
Stool frequency
Time frame: 5 days
A frequency of defecation of < 3 stools per day marked the effectiveness of the treatment.
Consistency of stools
Time frame: 5 days
The treatment was considered effective if the consistency of stools became semi-solid.
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 20 Mar 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.
Talha Hassan principal investigator
Children Hospital, Lahore, Pakistan
Muhammad Zeeshan study director
Children 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 Probiotic Bacillus Clausii 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 7 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 20 Mar 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?
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 20 Mar 2025.