Health Condition 1: null- Upper Respiratory Tract Infections
Conditions
Interventions
Intervention1: Bacillus clausii UBBC07: Pharmaceutical form: Suspension,
Dosing schedule in the study: Twice a day for 3 months (2 billion cfu/ 5ml)
Control Intervention1: Placebo: Pharmaceutical fo
Sponsors
Unique Biotech Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnostic Criteria: Suffering from URTI i.e. at least 6 URTIs episodes medically confirmed, with a maximum of 18, during the 1 Year before the study. 2.Ethical or legal considerations: Children whose parents or guardians of the children who are willing to give written informed consent or AV recording as per the regulatory requirement 3.Informed consent with AV recording by study participants
Exclusion criteria
Exclusion criteria: 1.Patient suffering from pneumonia or bronchiolitis at the time of enrolment visit 2. Patients who had underwent tonsillectomy or adenoidectomy 3.Patient with known significant systemic disease, i.e. hepatic and or renal disease 4.Patient with malignant disease 5.Patient with autoimmune disease and other systemic diseases related to immune system disorders 6.Patient with diseases of the gastrointestinal tract which would impair absorption of the study medication 7.Patient treated with the following medications: Antibiotics within one week before study start oral vaccination with live vaccine within 4 weeks before study start previous and/or concomitant immunosuppressive or immuno stimulating therapy within 3 months before study start. 8.concomitant treatment with corticosteroids 9.concomitant treatment with an investigational drug within 1 month before study start 10.Participation in another clinical trial within 3 months prior to study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The mean rate of URTIs in the probiotic group 2.Reduction in duration of RTI in 6 months. 3.Proportion of patients with recurrent URTIs 4.Severity of RTIâ??s as assessed from symptom score 5.Duration of RTIâ??s as assessed from patient diary 6.Type and duration of concomitant treatment. 7.Absenteeism: from daycare 8.Absenteeism: from work for parent. 9.Time to first RTI episode as assessed from parent questionnaire 10.4-7 years QOL questionnaireTimepoint: Screening to End of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in Immunity parameter - Changes in total IgG, IgM & IgE - Change in the levels of SIgA (saliva samples) by probiotic supplementation. 2.Assessment of safety of investigational product: I.Adverse event II.Physical examination III.Biomarker of systemic safety 1.Hematological â?? Haemogram 2.Hepatic - SGOT, SGPT 3.Renal - serum creatinine 4.Electrolytes Timepoint: Screening to End of Treatment | — |
Countries
India
Contacts
Public ContactDr Harisha s
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed