| CTRI Number |
CTRI/2022/12/048573 [Registered on: 28/12/2022] Trial Registered Prospectively |
| Last Modified On: |
27/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to assess the effects of a Bacillus coagulans-based product
on protein digestion 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
|
| Secondary ID |
Identifier |
| BIAG-CSP-035 Version No: 2.0 Dated 06 May 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ambrish C |
| Designation |
Principal Investigator |
| Affiliation |
Medstar Speciality Hospital |
| Address |
Medstar Speciality Hospital #641/17/1/3, kodigehalli main road, Sahakarnagar Bangalore-560092, Karnataka, India
Bangalore
KARNATAKA
560092
India |
| Phone |
08041127524 |
| Fax |
|
| Email |
medstarclinicalresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
Bioagile Therapeutics Pvt. Ltd |
| Address |
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka 560094 India
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapetics.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
Bioagile Therapeutics Pvt. Ltd |
| Address |
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka 560094 India
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapetics.com |
|
|
Source of Monetary or Material Support
|
| Abode Biotec India Private Limited Plot no: 34 A, Huda heights, 2nd floor, Road no:12 Banjara hills, near lotus pond, Telangana 500033. INDIA |
|
|
Primary Sponsor
|
| Name |
Abode Biotec India Private Limited |
| Address |
Plot no: 34 A, Huda heights, 2nd floor, Road no:12
Banjara hills, near lotus pond, Telangana 500033. INDIA
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ambrish C |
MedStar Speciality Hospital |
OPD Department, Room No-1, Ground Floor,
#641/17/1/3, Kodigehalli Main Road, Sahakarnagar, Bangalore- 560092, Karnataka, India
Bangalore
KARNATAKA |
080-41127524
medstarclinicalresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MedStar Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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. |
|
| ExclusionCriteria |
| Details |
1.Subject has a known allergy or sensitivity to any ingredient in the test product.
2.Subject on protein and/ or probiotic rich diet.
3.Subject has a history of alcohol or other drug abuse in the past year |
|
|
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
|
| Outcome |
TimePoints |
1.Primary outcome measure(s) will be change from baseline in Creatine Kinase and CRP
Score (measured after exercise bout) at day 1, week 4 and week8.
|
8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the symptoms and signs of protein absorption and digestion, based on evaluation on Creatine Kinase and CRP and Pain VAS for muscle soreness, at the end of therapy. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/01/2023 |
| 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="2"
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)?
Response - NO
|
|
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 for us especially for the digestive system. Probiotics are considered generally safe to consume.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.
|