A study to see the effect of supplement with Probiotic for prevention of diarrhea in children treated with antibiotic medicines.

Phase 4

Conditions: Health Condition 1: A499- Bacterial infection, unspecified

Registration Number: CTRI/2024/01/061328

Lead Sponsor: Sanzyme Biologics P Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of the incidence of antibiotic associated diarrheaTimepoint: Visit 1 – Screening or Baseline or Randomization <br/ ><br>Visit 2 – 2 Weeks (or earlier) upon completion of Antibiotic treatment <br/ ><br>Visit 3 – 2 weeks after discontinuation of antibiotic treatment <br/ ><br>Visit 4 – 4 weeks after discontinuation of antibiotic treatment <br/ ><br>Visit 5 – 6 weeks after discontinuation of antibiotic treatment <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Reduction in antibiotic-associated diarrhea events per day <br/ ><br>Reduction in severity of diarrhea events <br/ ><br>Reduction in GI related symptoms (nausea, vomiting, abdominal pain) <br/ ><br>Reduction in hospital days <br/ ><br>Timepoint: Visit 1 – Screening or Baseline or Randomization <br/ ><br>Visit 2 – 2 Weeks (or earlier) upon completion of Antibiotic treatment <br/ ><br>Visit 3 – 2 weeks after discontinuation of antibiotic treatment <br/ ><br>Visit 4 – 4 weeks after discontinuation of antibiotic treatment <br/ ><br>Visit 5 – 6 weeks after discontinuation of antibiotic treatment <br/ ><br>