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

Phase 2

Not yet recruiting

• Conditions: Evaluation of respiratory and GI symptoms

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

Brief Summary

Probiotics are known to enhance immunity and in this study the effect of Bacillus coagulans in decreasing the number of upper respiratory tract infections in children will be assessed. The frequency, severity & duration of symptoms of Upper respiratory tract in participants receiving Bacillus coagulansi n comparison to participants receiving placebo Gummies over a period of 3 months will be evaluated .In additions GI symptoms will be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-15
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

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 subject’s ability.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency, Severity & Duration of symptoms of Upper respiratory tract infections	Baseline, Day30, Day 60, Day 90

Secondary Outcome Measures

Name	Time	Method
Frequency of symptoms of GI origin	Number of episodes of respiratory tract and gastrointestinal (GI) symptoms.
Serum ferritin,serum transferrin(Tfr), serum albumin, folic acid, vitamin B12, Vitamin D, retinol and zinc	Baseline and end of study

Trial Locations

Locations (1)

KK Medicare; 🇮🇳 Mumbai, MAHARASHTRA, India

KK Medicare

🇮🇳Mumbai, MAHARASHTRA, India

Dr Mahesh Talekar

Principal investigator

9323153191

mktalekar78@gmail.com