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
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.
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- 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