| CTRI Number |
CTRI/2023/01/048720 [Registered on: 04/01/2023] Trial Registered Prospectively |
| Last Modified On: |
03/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to assess the effect of a Bacillus coagulans-based product on immunomodulation and stress levels |
|
Scientific Title of Study
|
A prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial to evaluate the effect of a Bacillus coagulans-based product on immunomodulation and stress levels. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIAG-CSP-036 Version No: 3.0, Dated 04 JUL 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 |
80-41127524
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 |
Immunomodulation and stress levels
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
106-108 CFU in the form of
powder to be reconstituted in
milk or water to be consumed in
morning and evening (one
each) for 8 weeks |
| Intervention |
Probiotic containing B.coagulans |
106-108 CFU in the form of
powder to be reconstituted in
milk or water to be consumed in
morning and evening (one
each) for 8 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male/female of age 18-65 years.
2.FBG (≤ 126 mg/dl).
3.Normal blood parameters (Hb ≥ 10 g/dl).
4.Subjects who understand the nature and purpose of the study
|
|
| ExclusionCriteria |
| Details |
1.Women who are pregnant or Lactating.
2.Subjects who are taking Antibiotic treatment
3.Subjects suffering from Gastrointestinal disease
4.Subjects suffering from Diabetes
5.Subjects suffering from Chronic/iatrogenic immunodeficiency
|
|
|
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 |
| Effect on the systemic and adaptive immune system will be measured by change in ISQ score from baseline to eight weeks of treatment between the intervention group and the placebo group |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Differences in hematological parameters such as CBC in-between the 2 groups over the study period.
2.Differences in Immune parameters such as Kidney Function, Liver Function IgG, IgM, IgA,Lipid Profile in-between the 2 groups over the study period |
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)
|
04/01/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Probiotic: Probiotics
are live microorganisms promoted with claims that they provide health benefits
when consumed, generally by improving or restoring the gut flora. Probiotics
are considered generally safe to consume. Bacillus coagulans is
a type of good bacteria, called a probiotic. It produces lactic acid, but isn’t
the same thing as Lactobacillus, another type of probiotic. It is one of
the most promising probiotics. The sponsor have developed the
probiotic strain called ProBCPlus for the management of immunomodulatory effects and
this study aims to evaluate the effect of a Bacillus
coagulans-based product on immunomodulation and stress levels in apparently
healthy subjects. |