None listed
Conditions
Interventions
Intervention1: Probiotic & prebiotic gummies: Bacillus coagulans gummies ( 1 billion cfu ) along with FOS will be given once daily for 90 days
Control Intervention1: Placebo: Placebo gummies will be g
Sponsors
Unique Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: Children attending school and able to provide assent.Children whose parent(s)/ caretakers have given written informed prior to study entry. Children who can comply with study procedures including follow-up. Children who have not taken vaccine in the last 4 weeks before randomization
Exclusion criteria
Exclusion criteria: Significant illness (including common cold) within the 2 weeks prior to intervention Any active systemic infection or medical condition that might require treatment or therapeutic intervention during the Study History of severe allergic reactions or anaphylaxis or any allergy to compounds of the investigational product to an extent that would jeopardize the subject or the study purpose as judged by the investigator. Treatment with immune modulatory or stimulating medication or botanicals/herbal supplements (e.g. Echinacea) and vaccines within 4 weeks before randomization in the study, antibiotic treatment 30 days before randomization. A history or current signs of perennial allergic rhinitis or asthma, influenza vaccination within 3 months before the start of the intervention. Caregiver/caregivers smoking at home, regular consumption of probiotics and prebiotics as food supplements in the past 3 months before randomization. Regular consumption of probiotics or probiotic fermented milk, immunosuppressive, and laxative agents in 4 weeks prior to randomization. Participation in another clinical trial during the last 4 weeks prior to the beginning of this study. Incapability to comply with the study procedures. Any other reason which in the opinion of the Investigator might either put the subject at risk because of participation in the study or influence the results or the subjectâ??s ability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency, Severity & Duration of symptoms of Upper respiratory tract infections Timepoint: Baseline, Day30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of symptoms of GI origin Number of episodes of respiratory tract and gastrointestinal (GI) symptoms. Severity of gastrointestinal (GI) symptoms. School absenteeism due to respiratory symptoms and gastrointestinal (GI) symptoms. BMI at screening and end of study. Eosinophil counts at baseline and end of study. Assessment of GI questionnaire Change from baseline in IgG,IgA, IgM and IgE at baseline and end of study. Biomarkers like - TNFalpha, IFNgamma, IL4, IL6, IL-8, PF-4 and uPAR , CD163, GM-CSF, CAM-1 status at baseline and end of study Timepoint: Baseline, Day30, Day 60, Day 90;Serum ferritin,serum transferrin(Tfr), serum albumin, folic acid, vitamin B12, Vitamin D, retinol and zincTimepoint: Baseline and end of study | — |
Countries
India
Contacts
Public ContactJayanthi Neelamraju
Unique Biotech Limited
Outcome results
None listed