| CTRI Number |
CTRI/2023/04/051660 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
17/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the effects of a Bacillus coagulans-based product on protein absorption. |
|
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 absorption. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIAG-CSP-035 Version No: 1.0 Dated 04 Mar 2023 |
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
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
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.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
Bangalore
KARNATAKA
560094
India
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.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
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 |
2 sachets to be taken orally with water twice daily, at approximately the same time each day, preferably morning and night for 8 weeks |
| Intervention |
Standard protein mix and Probiotic containing B. coagulans |
2 sachets to be taken orally with water twice daily, at approximately the same time each day, preferably morning and night for 8 weeks |
|
|
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 (both inclusive).
4.Subject is in good health as determined by Principal Investigator |
|
| 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 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. |
|
|
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.Change in urine urea nitrogen for Bacillus coagulans-based product on protein absorption
2.Short Health Scale for GI symptoms (SHS-GI) for Bacillus coagulans-based product on protein absorption
3.Food frequency questionnaire (FFQs) |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of Bacillus coagulans-based product on protein absorption |
8 Weeks |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/05/2023 |
| 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)
|
Open to Recruitment |
| 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 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 Diarrhoea, showed positive significant effects. Understanding the above facts, 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. |