Health Condition 1: J069- Acute upper respiratory infection,unspecified
Conditions
Interventions
Intervention1: Streptococcus salivarius K12 probiotic lozenge: The dose of the Streptococcus salivarius K12 probiotic lozenge is one lozenge daily, before going to sleep after brushing teeth for 90 da
Sponsors
Dr Reddy’s Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children aged 3-6 years (male and female subjects) at the enrolment. 2.Children with symptoms/history of recurrent URTI/acute otitis media, and repeated episodes of common cold or flu. 3.Children who experienced 3 or more episodes of any upper respiratory tract infections viz streptococcal infection, viral infection etc. within 1 year from screening. 4.Children with no flu vaccination. 5.Children/Children’s parent who are willing to avoid any other probiotic supplements or dairy probiotic products (probiotic yoghurt, acidophilus milk, kefir etc.) for the duration of the study. 6.Parents/LAR who are able to understand written instructions and are ready to comply with all study requirements with a willingness to participate their child and give written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1.Children suffering from pneumonia or bronchiolitis at the time of screening. 2.Children who had underwent tonsillectomy or adenoidectomy. 3.Children with known significant systemic disease (i.e, hepatic and or renal disease), malignant disease, autoimmune disease, other systemic diseases related to immune system disorders and diseases of the gastrointestinal tract which would impair absorption of the study medication. 4.Children treated with the following medications: Antibiotics within one week before enrolment in the study, oral vaccination with live vaccine within 4 weeks before enrolment in the study, previous and/or concomitant immunosuppressive or immuno stimulating therapy including (vitamin –C, zinc, pidotimod, etc.) within 3 months before enrolment in the study. 5.Participation in another clinical trial within 3 months prior to enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in the number of episodes of the recurrent URTI as compared to control arm from baseline to day 90, day 180 and day 270 (end of the study). 2. Reduction in the duration of the recurrent URTI as compared to control arm from baseline to day 90, day 180 and day 270 (end of the study). Timepoint: day 90, day 180 and day 270 (end of the study). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1. Reduction in the number of days under antibiotic treatment as compared to control arm at day 90, day 180 and day 270 (the end of the study). 2. Reduction in the number of days under other drugs treatment like antipyretic, antihistamines as compared to control arm at day 90, day 180 and day 270 (the end of the study). 3. Physician and subject’s parent satisfaction on the study treatment as compared to baseline at the end of the study. 4. Reduction in time (days or hours) missed from pre-school or school (subjects) as compared to control arm at the end of the study. 5. Reduction in time (days or hours) missed from work (parent/guardian) due to subject’s illness as compared to control arm at the end of the study. Safety: 1. Number of adverse event (other than study indication) and serious adverse events in both study arms during treatment period from baseline to day 90. Timepoint: day 90, day 180 and day 270 (the end of the study). | — |
Countries
India
Contacts
Public ContactDr Rahul Rathod
Dr. Reddys Laboratories
Outcome results
None listed