Health Condition 1: R197- Diarrhea, unspecified
Conditions
Interventions
Intervention1: Sporlac Powder and Standard of Care: 150 million spores of Lactic Acid Bacillus in 6 months to 8 years Twice daily from Day 1 to Day 5
Intervention2: Sporlac DS Tablet and Standard of C
Sponsors
J. B. chemicals & pharmaceuticals LTD.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pediatric male and female patients aged 6 months to 18 years. 2. Patients diagnosed with acute diarrhea, characterized by the sudden onset of more than 3 loose or watery stools within 24 hours. 3. Parent of patient willing to provide written informed consent for their children. 4. Parent of patient (or their legal guardians, where applicable) willing to complete subject diaries and respond to study questionnaires, including daily documentation of stool frequency, stool consistency, and other efficacy parameters in diary card or willing to document all the details telephonically to CRC on daily basis. 5. Parent of patient with access to a functioning telephone for study-related communication. 6. Patients in generally good health, with no known significant underlying medical conditions that could interfere with study outcomes.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Sporlac Powder/ DS Tablet or any component of the formulation. 2. Severe dehydration requiring hospitalization or any patient with symptoms of dehydration needing inpatient care at the time of study enrolment. 3. Patients currently on medications that may interact with Sporlac or those on concurrent medications that could interfere with the study outcomes or standard treatment for diarrhea. 4. Recent use of non-prescribed probiotic supplements or anti-diarrheal (including products containing live cultures, such as yogurt) or antibiotics within the last seven days for the treatment of diarrhea. 5. Patients with known significant uncontrolled medical conditions, including chronic gastrointestinal disorders (except irritable bowel disease) or other systemic diseases. 6. Clinically significant signs or symptoms indicative of parasitic or bacterial diarrhea. 7. Current presence of blood, pus, or mucus in stools, or a history of these symptoms within the previous 3 months. 8. Persistent diarrhea, defined as a duration exceeding 14 days. 9. Severe or persistent vomiting that may interfere with study participation or outcomes. 10. Participation in another clinical trial within the last 30 days. 11. Pregnant or breastfeeding women, or women of childbearing potential 12. Not willing to comply with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool frequency over treatment duration in the two groups.Timepoint: At the end of treatment (Day 5) | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool consistency using Bristol stool scale over treatment duration in the two groups.Timepoint: At the end of treatment (Day 5);Time to first formed stool after initiation of treatmentTimepoint: Baseline Vs End if Treatment (Day 5);Abdominal pain score using NRS (more than 8 years) or over treatment duration in the two groups.Timepoint: Baseline Vs End of Treatment (Day 5);Presence or absence of other associated abdominal symptoms during treatment periodTimepoint: Baseline Vs End of Treatment (Day 5);Adverse events reported during the studyTimepoint: At the End of Study (Day 5);Serious adverse events reported during the studyTimepoint: At the End of Study (Day 5) | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Clinexcel Research
Outcome results
None listed