| CTRI Number |
CTRI/2020/07/026453 [Registered on: 09/07/2020] Trial Registered Prospectively |
| Last Modified On: |
21/03/2022 |
| 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 Controlled parallel-group 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
Modification(s)
|
| Secondary ID |
Identifier |
| BIAG-CSP-036 Version Number: 2.0 Date: 17 February 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajanna Muniswamyappa |
| Designation |
Consultant |
| Affiliation |
Arogyavardhini Ayurvedic Centre |
| Address |
No:2, 5th Cross, Giddappa Layout, Kammanahalli, St Thomas Town Post,
Bangalore
KARNATAKA
560084
India |
| Phone |
8660620501 |
| Fax |
|
| Email |
mdrrajanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini Dayananda |
| Designation |
Associate Vice President |
| Affiliation |
BioAgile Therapeutics Pvt Ltd |
| Address |
#2/5, 3rd Floor Dahlia Building, 80ft Road, RMV 2nd Stage,
Bangalore
KARNATAKA
560094
India |
| Phone |
08043754520 |
| Fax |
|
| Email |
pm@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,
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
|
|
|
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, Near Tender Chicken,
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
immunomodulation and stress |
|
|
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). |
| Intervention |
Probiotic containing B. coagulans (8 wks) |
106-108 CFU in the form of powder to be reconstituted in milk or water to be consumed in morning and evening (one each)(8 wks) |
|
Inclusion Criteria
Modification(s)
|
| 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
including the potential risks and side effects.
5. Subjects who are willing to complete all study procedures
including study related questionnaires and comply with study
requirements.
6. Subjects who have given voluntary, written, informed consent to participate in 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
6. Subjects suffering from Abnormal blood pressure
7. Subjects who are allergic to ingredients of the study
product
8. Subjects who are using any other pre/pro/symbiotic
product.
9. Subjects who are Smoker or alcoholic
10. Subjects who have participated prior in conflicting clinical trial or have participated in the trial over the last 3months.
|
|
|
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. Immune Status Questionnaire (ISQ Score)
2. Perceived Stress Scale - 10 (PSS -10)
Differences in hematological parameters (complete blood cell count, lipid profile, kidney and liver function parameters) between the intervention group and the placebo group over the study period. |
Day1, Week 4 and week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Differences in haematological parameters between the intervention group and the placebo group over the study period |
Day1, Week 4 and week 8 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2020 |
| 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)
Modification(s)
|
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 considered generally safe to consume. They offer numerous health benefits, including digestive and immune health. Improved digestive health is linked to a more efficient absorption of important nutrients from our diet. 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. |