Health Condition 1: A499- Bacterial infection, unspecified
Conditions
Interventions
Intervention1: Bacillus clausii strains of SNZCLB 1, SNZCLB 2, SNZCLB 3 and SNZCLB 4: Probiotic Bacillus clausii SNZCLB 1, SNZCLB 2, SNZCLB 3, SNZCLB 4 -
2 Billion CFU per 5mL and Beta Lactam Antibio
Sponsors
Sanzyme Biologics P Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Mild to moderate infection of the respiratory, genito-urinary or skin and soft tissue admitted or consulted at the out patient for treatment of bacterial infection requiring Beta lactam antibiotic treatment for 5 to 14 days.
Exclusion criteria
Exclusion criteria: 1. Clinically unstable infants and children 2. Subjects with critical illness, chronic diseases of the endocrine, cardiovascular, renal, or respiratory system (or any other clinically significant condition that might jeopardize a patient’s condition or study outcomes in the view of the Investigator), 3. a history of or current presence of conditions known to produce immunodeficiency (congenital or acquired immunodeficiency syndromes, immunosuppressant therapy), 4. presence of an in-dwelling vascular access line, a history of or current pancreatitis, history of abdominal surgery, bilious emesis, or 5. participation in another clinical trial within the past 3 months. 6. hypersensitivity to B. clausii or excipients in the investigational medical product or to other probiotics. 7. long-term use of oral or intravenous corticosteroids within 6 months of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the incidence of antibiotic associated diarrheaTimepoint: Visit 1 – Screening or Baseline or Randomization Visit 2 – 2 Weeks (or earlier) upon completion of Antibiotic treatment Visit 3 – 2 weeks after discontinuation of antibiotic treatment Visit 4 – 4 weeks after discontinuation of antibiotic treatment Visit 5 – 6 weeks after discontinuation of antibiotic treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in antibiotic-associated diarrhea events per day Reduction in severity of diarrhea events Reduction in GI related symptoms (nausea, vomiting, abdominal pain) Reduction in hospital days Timepoint: Visit 1 – Screening or Baseline or Randomization Visit 2 – 2 Weeks (or earlier) upon completion of Antibiotic treatment Visit 3 – 2 weeks after discontinuation of antibiotic treatment Visit 4 – 4 weeks after discontinuation of antibiotic treatment Visit 5 – 6 weeks after discontinuation of antibiotic treatment | — |
Countries
India
Contacts
Public ContactDr Kishan PV
Sanzyme Biologics P Ltd
Outcome results
None listed