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CTRI Number  CTRI/2020/07/026454 [Registered on: 09/07/2020] Trial Registered Prospectively
Last Modified On: 17/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Controlled parallel-group clinical study to assess the effects of a Bacillus coagulans-based product on protein digestion and utilization in gastro-intestinal tract. 
Scientific Title of Study   A prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial to evaluate the effects of a Bacillus coagulans-based product on protein digestion and utilization in gastro-intestinal tract. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
BIAG-CSP-035 Version Number:2.0 Date: 06 May 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajanna M 
Designation  Consultant –Physician 
Affiliation  Arogyavardhini Ayurvedic Centre 
Address  Arogyavardhini Ayurvedic Centre No:2, 5th Cross, Giddappa Layout,Kammanahalli, St Thomas Town Post, Bangalore

Bangalore
KARNATAKA
560084
India 
Phone  8660620501  
Fax    
Email  mdrrajanna@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Divya C 
Designation  CEO 
Affiliation  Bio Agile Therapeutics Pvt. Ltd 
Address  #2/5, 3rd Floor Dahlia Building, 80 Feet road, RMV 2nd Stage, Bangalore

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Divya C 
Designation  CEO 
Affiliation  Bio Agile Therapeutics Pvt. Ltd 
Address  #2/5, 3rd Floor Dahlia Building, 80 Feet road, RMV 2nd Stage, Bangalore

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Sponsored trial- Abode Biotec India Private Limited. Telangana 
 
Primary Sponsor  
Name  Abode Biotec India Private Limited 
Address  Banjara hills, near lotus pond, Telangana 500033 
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 Rajanna M  Arogyavardhini Ayurvedic Centre  No:2, 5th Cross, Giddappa Layout, Kammanahalli, St Thomas Town Post, Bangalore-560084
Bangalore
KARNATAKA 		 8660620501

mdrrajanna@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Protein Absorption and GI Health 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  1 to 2 sachet to be taken orally with water once daily, at approximately the same time each day, preferably morning and night for 8weeks. 
Intervention  Standard protein mix and Probiotic containing B. coagulans   1 to 2 sachet to be taken orally with water once daily, at approximately the same time each day, preferably morning and night for 8weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subject has provided written and dated informed consent to participate in the study.
2. Subject is willing and able to comply with the protocol.
3. Healthy male/female of age 18-60 years.
4. Subject is in good health as determined by a health history questionnaire.
5. Subject ready to follow the diet and exercise regime.
6. Subject is untrained in resistance/power exercise
 
 
ExclusionCriteria 
Details  1. Subject on protein and/ or probiotic rich diet.

2. Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrolment.

3. Subject has a history of alcohol or other drug abuse in the past year

4. Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, high blood pressure (BP) [systolic BP> 140 and/or diastolic BP> 90], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.

5. Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study.

6. Subject has a known allergy or sensitivity to any ingredient in the test product.

7. Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.

8. Subject has a history of difficulty swallowing large pills or tablets
9. Subject has a history of orthopaedic injury or surgery within the last year.

10. Subject has any physical condition considered a contraindication to the type of exercise performed in the study.
11. Subject has had an abnormal resting ECG.

12. Investigator is uncertain about subject’s capability or willingness to comply with the protocol requirements.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Difference in the Creatine Kinase and CRP levels
between the intervention group and the placebo
group
 		 Time Frame: baseline Day 0, week 8 
 
Secondary Outcome  
Outcome  TimePoints 
Differences in muscle soreness pain VAS between the intervention group and the placebo group over the study period.   Time Frame: baseline (Day 1, wk 4, wk 8] 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)
Modification(s)  		 20/06/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Probiotics are live microorganisms promoted with claims that they provide health benefits when consumed, generally by improving or restoring the gut flora. Probiotics are live bacteria and yeasts that are good us especially for the digestive system.

Probiotics are considered generally safe to consume. Probiotics had a positive significant effect across all eight gastrointestinal diseases with a relative risk of 0.58 (95% (CI) 0.51–0.65). Six of the eight diseases: Pouchitis, Infectious diarrhoea, Irritable Bowel Syndrome, Helicobacter pylori, Clostridium difficile Disease, and Antibiotic Associated Diarrhea, showed positive significant effects.

The sponsor has developed the probiotic strain of BC, called as ProBCPlus. The aim of the current clinical trial is to evaluate the effects of a Bacillus coagulans-based product on protein digestion and utilization in gastro-intestinal tract in healthy human volunteers.


 
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