Acute Watery DiarrheaNCT07660367
Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children
A study testing Enterogermina and Ecotec in people with Acute Watery Diarrhea, run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.
Trial summary
This randomized controlled trial will compare Bacillus clausii (Enterogermina) and a multistrain probiotic preparation (Ecotec) in children aged 1-5 years with acute watery diarrhea. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Acute Watery Diarrhea
- What is being tested?
- Enterogermina and Ecotec
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Sep 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient with Acute watery diarrhea aged 1 year to 5 years.
- Both genders will be included.
- Patients whose guardians/ parents will give informed consent will participate in the study.
- Patients having mild to moderate dehydration will be included in study.
- Patients having mild to moderate malnutrition will be included in study.
Who cannot join
- Children having history of chronic diarrhea.
- Children having history of blood in stools.
- Children having cholera.
- Children with evidence of concurrent systemic infections other than acute diarrhea (e.g. respiratory tract infections, urinary tract infections, measles, meningitis etc).
- Children with known immunodeficiency disorders or undergoing immunosuppressive treatments (e.g., chemotherapy, corticosteroids).
- Children who have received antibiotics or zinc within the past 72 hours prior to enrollment, as this may interfere with gut flora and probiotic efficacy.
Show all 9Show fewer
- Children who have received probiotics as a treatment for the current episode of diarrhea prior to study enrollment.
- Children with known allergies or hypersensitivity to probiotic components used in the study.
- Children who needed I/V antibiotics or I/V rehydration after enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Children Hospital and Institute of Child Health, Lahore
Lahore, Punjab Province, 54000
Mamoona feroz, +923315616443, mamoona.feroz@yahoo.com
About this study
Official title: Comparison of Effectiveness of Bacillus Clausii and Multistrain Probiotics (Lactobacillus Acidophilus, Lactobacillus Bulgaricus, Bifidobacterium, Streptococcus Thermophilus) in the Management of Children With Acute Watery Diarrhea: A Randomised Controlled Trial
This randomized controlled trial will compare Bacillus clausii (Enterogermina) and a multistrain probiotic preparation (Ecotec) in children aged 1-5 years with acute watery diarrhea. Participants will receive one of the probiotic treatments along with standard therapy including oral rehydration solution and zinc supplementation. The study will evaluate the duration of diarrhea, stool frequency, and stool consistency.
Read the detailed description
Acute watery diarrhea is a major cause of morbidity among children worldwide, particularly in developing countries. Although oral rehydration solution (ORS) and zinc supplementation remain the cornerstone of treatment, probiotics are increasingly used as adjunctive therapy to reduce the duration and severity of illness.
Bacillus clausii and multistrain probiotic preparations have both demonstrated beneficial effects in children with acute diarrhea. However, evidence comparing their relative effectiveness is limited. This study aims to compare the effectiveness of Bacillus clausii (Enterogermina) and a multistrain probiotic preparation (Ecotec) containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus in the management of acute watery diarrhea in children.
This study is a randomized, open-label, parallel-group controlled trial conducted in the Department of Pediatric Medicine at The Children's Hospital and Institute of Child Health, Lahore. A total of 138 children aged 1-5 years with acute watery diarrhea will be enrolled and randomized in a 1:1 ratio into two treatment groups.
Participants in Group A will receive Bacillus clausii (Enterogermina) once daily for 5 days in addition to ORS and zinc supplementation. Participants in Group B will receive the multistrain probiotic preparation (Ecotec) once daily for 5 days in addition to ORS and zinc supplementation.
The primary outcome is duration of diarrhea. Secondary outcomes include stool frequency and stool consistency during the treatment period. The findings of this study may help identify the more effective probiotic strategy for the management of acute watery diarrhea in children and contribute to evidence-based pediatric practice.
- Conditions
- Acute Watery Diarrhea
- Being tested
- Enterogermina, Ecotec
- Keywords
- Bacillus clausii, Multistrain probiotics, Acute watery diarrhea, Children, Randomised controlled trial, Zinc supplementation, Oral rehydration solution
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnterogerminaDrug
Bacillus clausii oral suspension containing 2 billion spores administered once daily for 5 days.
EcotecDrug
Multistrain probiotic preparation containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus administered once daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Bacillus clausii Group | Active comparator | Participants will receive Bacillus clausii (Enterogermina) once daily for 5 days in addition to standard treatment with oral rehydration solution (ORS) and zinc supplementation. Receives: Drug: Enterogermina |
| Multistrain Probiotic Group | Active comparator | Participants will receive a multistrain probiotic preparation (Ecotec) once daily for 5 days in addition to standard treatment with oral rehydration solution (ORS) and zinc supplementation. Receives: Drug: Ecotec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Diarrhea
The duration of acute diarrhea is determined by the timeframe (measured in days) spanning from the initial occurrence of abnormal (loose or liquid) stools to the subsequent return of normal stool consistency. This assessment will consider both the frequency of daily stools and their consistency.
Measured: Up to 5 days after initiation of treatment
Secondary outcomes (2)
Daily Stool Frequency
Number of stools passed per day during the treatment period.
Measured: Daily for 5 days after initiation of treatment
Stool Consistency
Change in stool consistency assessed daily during the treatment period.
Measured: Daily for 5 days after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start18 Sep 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
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
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children Hospital and Institute of Child Health, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mamoona Feroz, Children Hospital and Institute of Child Health, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660367
- Sponsor's protocol ID
- UCHS-MDPEDS-2026-01
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Bacillus Clausii and Multistrain Probiotics (Lactobacillus Acidophilus, Lactobacillus Bulgaricus, Bifidobacterium, Streptococcus Thermophilus) in the Management of Children With Acute Watery Diarrhea: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07660367
- Acronym / sponsor ID
- UCHS-MDPEDS-2026-01
- Conditions
- Acute Watery Diarrhea
- Keywords
- Bacillus clausii, Multistrain probiotics, Acute watery diarrhea, Children, Randomised controlled trial, Zinc supplementation, Oral rehydration solution
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Children Hospital and Institute of Child Health, LahoreUniversity, hospital or other
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Jun 2026 (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 randomized controlled trial will compare Bacillus clausii (Enterogermina) and a multistrain probiotic preparation (Ecotec) in children aged 1-5 years with acute watery diarrhea. Participants will receive one of the probiotic treatments along with standard therapy including oral rehydration solution and zinc supplementation. The study will evaluate the duration of diarrhea, stool frequency, and stool consistency.
Detailed description
Acute watery diarrhea is a major cause of morbidity among children worldwide, particularly in developing countries. Although oral rehydration solution (ORS) and zinc supplementation remain the cornerstone of treatment, probiotics are increasingly used as adjunctive therapy to reduce the duration and severity of illness.
Bacillus clausii and multistrain probiotic preparations have both demonstrated beneficial effects in children with acute diarrhea. However, evidence comparing their relative effectiveness is limited. This study aims to compare the effectiveness of Bacillus clausii (Enterogermina) and a multistrain probiotic preparation (Ecotec) containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus in the management of acute watery diarrhea in children.
This study is a randomized, open-label, parallel-group controlled trial conducted in the Department of Pediatric Medicine at The Children's Hospital and Institute of Child Health, Lahore. A total of 138 children aged 1-5 years with acute watery diarrhea will be enrolled and randomized in a 1:1 ratio into two treatment groups.
Participants in Group A will receive Bacillus clausii (Enterogermina) once daily for 5 days in addition to ORS and zinc supplementation. Participants in Group B will receive the multistrain probiotic preparation (Ecotec) once daily for 5 days in addition to ORS and zinc supplementation.
The primary outcome is duration of diarrhea. Secondary outcomes include stool frequency and stool consistency during the treatment period. The findings of this study may help identify the more effective probiotic strategy for the management of acute watery diarrhea in children and contribute to evidence-based pediatric practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacillus clausii Group | Active comparator | Drug: EnterogerminaParticipants will receive Bacillus clausii (Enterogermina) once daily for 5 days in addition to standard treatment with oral rehydration solution (ORS) and zinc supplementation. |
| Multistrain Probiotic Group | Active comparator | Drug: EcotecParticipants will receive a multistrain probiotic preparation (Ecotec) once daily for 5 days in addition to standard treatment with oral rehydration solution (ORS) and zinc supplementation. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patient with Acute watery diarrhea aged 1 year to 5 years.
- Both genders will be included.
- Patients whose guardians/ parents will give informed consent will participate in the study.
- Patients having mild to moderate dehydration will be included in study.
- Patients having mild to moderate malnutrition will be included in study.
Key exclusion criteria (9 listed)
- Children having history of chronic diarrhea.
- Children having history of blood in stools.
- Children having cholera.
- Children with evidence of concurrent systemic infections other than acute diarrhea (e.g. respiratory tract infections, urinary tract infections, measles, meningitis etc).
- Children with known immunodeficiency disorders or undergoing immunosuppressive treatments (e.g., chemotherapy, corticosteroids).
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 |
|---|---|---|
| EnterogerminaBacillus clausii oral suspension containing 2 billion spores administered once daily for 5 days. | Drug | Bacillus clausii Group |
| EcotecMultistrain probiotic preparation containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus administered once daily for 5 days. | Drug | Multistrain Probiotic Group |
Primary outcome
Duration of Diarrhea
Time frame: Up to 5 days after initiation of treatment
The duration of acute diarrhea is determined by the timeframe (measured in days) spanning from the initial occurrence of abnormal (loose or liquid) stools to the subsequent return of normal stool consistency. This assessment will consider both the frequency of daily stools and their consistency.
2 secondary outcomes
Daily Stool Frequency
Time frame: Daily for 5 days after initiation of treatment
Stool Consistency
Time frame: Daily for 5 days after initiation of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Watery Diarrhea
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Active, not recruiting
Comparison of Bacillus Clausii and Saccharomyces Boulardii for Acute Diarrhea at Day 3
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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
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enterogermina and Ecotec in people with Acute Watery Diarrhea, run by Children Hospital and Institute of Child Health, Lahore 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mamoona feroz (+923315616443, mamoona.feroz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Diarrhea (time frame: Up to 5 days after initiation of treatment). 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 13 Oct 2026.