A clinical study to study the effect of Bacillus coagulans on immunity in childre

Phase 2

• Registration Number: CTRI/2022/11/047321
• Lead Sponsor: nique Biotech Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified