Health Condition 1: R197- Diarrhea, unspecified
Conditions
Interventions
Intervention1: Sporlac Powder + Standard of Care: Twice daily 150 million spores of Lactic Acid Bacillus in 6 months to 8 years of age From Day 1 to Day 5
Intervention2: Sporlac DS Tablet + Standard o
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 prescribed with oral antibiotic therapy expected to be administered for 5 to 14 days, consisting of one of the following: amoxicillin (with or without clavulanate) or third-generation cephalosporins (e.g., cefixime, ceftibuten, cefdinir, cefpodoxime, cefditoren), for various medical conditions. 3. Parent of patient with access to a functioning telephone for study-related communication. 4. Parent of patient willing to provide written informed consent for their children. 5. 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. Antibiotic treatment for the last four weeks before inclusion in the study. 3. Patients requiring hospitalization. 4. Patients currently on medications that may interact with Sporlac or those on concurrent medications that could interfere with the study outcomes. 5. Patients currently on tube-feeding, use of proton-pump inhibitors, laxatives or anti-diarrhoeal drugs, in the last four weeks before inclusion in the study. 6. Recent use of non-prescribed probiotic supplements (including products containing live cultures) within the last seven days. 7. Patients with known significant uncontrolled medical conditions, except that being treated by prescribed anti-biotic. 8. Patients with known history of pre-existing diarrhea within the previous 4 weeks 9. Participation in another clinical trial within the last 30 days. 10. Pregnant or breastfeeding women, or women of childbearing potential 11. Not willing to comply with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Sporlac in the preventing antibiotic-associated diarrhea.Timepoint: 10 Days after completion of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of Sporlac in the preventing antibiotic-associated diarrhea.Timepoint: Day 1 to 10 Days after completion of Treatment | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Clinexcel Research
Outcome results
None listed