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CTRI Number  CTRI/2022/11/047321 [Registered on: 15/11/2022] Trial Registered Prospectively
Last Modified On: 15/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to study the effect of Bacillus coagulans on immunity in children 
Scientific Title of Study   Evaluation of Bacillus coagulans Unique IS-2 on Upper Respiratory tract symptoms in school going children: a randomized, double‐blind, placebo‐controlled clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh Talekar  
Designation  Clinic Head  
Affiliation  KKMedicare 
Address  Shop 7/1/2 KK Estate TJRoad, Opp Dosti Flamingo Gate No.2, Sewri(West) Mumbai

Mumbai
MAHARASHTRA
400015.
India 
Phone  9323153191  
Fax    
Email  mktalekar78@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jayanthi Neelamraju 
Designation  Head- Scientific Affairs  
Affiliation  Unique Biotech Limited  
Address  Plot no 2 Phase II MN Park Kolthur village Shameerpet mandal,Medchal Malkajgiri dist Hyderabad

Hyderabad
TELANGANA
500101
India 
Phone  040423751346  
Fax    
Email  jayanthi@uniquebiotech.com  
 
Details of Contact Person
Public Query  
Name  Jayanthi Neelamraju 
Designation  Head- Scientific Affairs  
Affiliation  Unique Biotech Limited  
Address  Plot no 2 Phase II MN Park Kolthur village Shameerpet mandal,Medchal Malkajgiri dist Hyderabad

Hyderabad
TELANGANA
500101
India 
Phone  040423751346  
Fax    
Email  jayanthi@uniquebiotech.com  
 
Source of Monetary or Material Support  
Unique Biotech Ltd 
 
Primary Sponsor  
Name  Unique Biotech Limited  
Address  Unique Biotech Limited Plot no.2, Phase-II, M.N. Park, Kolthur village, Shameerpet mandal Medchal Malkajgiri dist Hyderabad, Telangana, 500 101, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahesh Talekar   KK Medicare  Shop no.7/1/2, K.K. Estate. Modi Chawl, T.J.Road, Opp Dosti Flamingo Gate No.2, Sewri(West), Mumbai -400015.
Mumbai
MAHARASHTRA 		 9323153191

mktalekar78@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Royal Pune Independent Ethics Committee (RPIEC)  Approved 
Royal Pune Independent Ethics Committee (RPIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Evaluation of respiratory and GI symptoms  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo   Placebo gummies will be given once daily for 90 days 
Intervention  Probiotic & prebiotic gummies   Bacillus coagulans gummies ( 1 billion cfu ) along with FOS will be given once daily for 90 days 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  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

 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Frequency, Severity & Duration of symptoms of Upper respiratory tract infections

 		 Baseline, Day30, Day 60, Day 90 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
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
 		 Baseline, Day30, Day 60, Day 90 
Serum ferritin,serum transferrin(Tfr), serum albumin, folic acid, vitamin B12, Vitamin D, retinol and zinc  Baseline and end of study  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/11/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
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