| CTRI Number |
CTRI/2023/01/048914 [Registered on: 11/01/2023] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Evaluate Clinical Safety of Heat Inactivated Bacillus coagulans in Healthy Human Participants. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Two-arm, Parallel Study to Evaluate Clinical Safety of Heat Inactivated Bacillus coagulans (Weizmannia coagulans) MTCC 5856 (Sami-Sabinsa Group Limited, India) in Healthy Human Participants. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| G7SYN/P-002/2022, Version No-01, Dated 12-10-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Alexander |
| Designation |
Medical Monitor |
| Affiliation |
G7 Synergon Private Limited |
| Address |
Clinical Research Department, 1st floor, No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India
Bangalore
KARNATAKA
560092
India |
| Phone |
9916252529 |
| Fax |
|
| Email |
ajay.alexander@g7synergon.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Sathish Kumar |
| Designation |
Managing Director |
| Affiliation |
G7 Synergon Private Limited |
| Address |
1st floor, Clinical Research department, No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India
Bangalore
KARNATAKA
560092
India |
| Phone |
9677014651 |
| Fax |
|
| Email |
sathishkumar@g7synergon.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Sathish Kumar |
| Designation |
Managing Director |
| Affiliation |
G7 Synergon Private Limited |
| Address |
1st floor, Clinical Research department, No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India
Bangalore
KARNATAKA
560092
India |
| Phone |
9677014651 |
| Fax |
|
| Email |
sathishkumar@g7synergon.in |
|
|
Source of Monetary or Material Support
|
| Sami-Sabinsa Group Limited
(Formerly known as Sami Labs Limited) 19/1 and 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore - 560 058,Karnataka, India
|
|
|
Primary Sponsor
|
| Name |
Sami-Sabinsa Group Limited |
| Address |
19/1 and 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore - 560 058, Karnataka, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivnitwar Sachin Kisan |
Lifepoint Multispeciality Hospital |
145/1, Mumbai Bangalore highway, Near Hotel Sayaji, Wakad, Pune-411057, Maharashtra
Pune
MAHARASHTRA |
9730475068
sachinshivnitwar94@gmail.com |
| Dr Vishwanath Patil |
Ojas Multispeciality Hospital |
D.Y.Patil College Road, Ravet, Pune-412101, Maharashtra
Pune
MAHARASHTRA |
9405024104
9405024104
vishwan100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Lifepoint Research - Ethics Committee |
Approved |
| Ojas Multispeciality Hospital Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Participants in clinical investigative sites |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Heat-inactivated Bacillus coagulans MTCC 5856 Capsule (150 mg) equivalent to 2 billion spores of Bacillus coagulans before heat inactivation. |
The participants shall be instructed to consume one capsule every night after dinner for 30 days starting on Day 1 with approximately 240 ml of water at ambient temperature. |
| Comparator Agent |
Vehicle of test product Capsule containing 150 mg of Maltodextrin |
The participants shall be instructed to consume one capsule every night after dinner for 30 days starting on Day 1 with approximately 240 ml of water at ambient temperature. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male or non-pregnant, non-lactating female participants aged between 18 to 49 years both inclusive and having Body Mass Index (BMI) ≤28 Kg/m2.
2. Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation at baseline measurement.
3. Participant willing to refrain from consuming probiotic and postbiotic supplements during the study.
4. Participant able to swallow and retain orally administered medication.
5. Female participant of childbearing potential practicing an approved method of contraception and willing to continue its use throughout the study duration or female participant of non-childbearing potential.
6. Participant willing and able to provide written informed consent before any study procedures are performed.
7. Participant shall be willing and able to understand and comply with the requirements of the study, consume the Investigational Product as instructed, return at the appropriate scheduled visits, comply with therapy prohibitions, and be able to complete the study.
|
|
| ExclusionCriteria |
| Details |
1. Females who are planning to become pregnant in three months or have a positive pregnancy test (females of childbearing potential) at screening.
2. Participant who has not taken two doses of vaccination for COVID-19 as per the government guidelines.
3. Participant education level below 8th grade of schooling.
4. Participant with or having a prior history of clinically significant diseases/disorders and/or any kind of allergy.
5. Participant with inflammatory, autoimmune diseases, diabetes, lactose intolerance, immune deficiency, hyperthyroidism or non-medically adjusted hypothyroidism, and coeliac disease.
6. Participant with or having a prior history of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease.
7. History of organ transplantation.
8. Participant has undergone surgery during the last six months.
9. Use of antipsychotic medications within 3 months before the start of the study.
10. Use of systemic corticosteroids within 1 month before the start of the study.
11.Use of vitamin/ mineral/ dietary or herbal supplements within 15 days before the start of the study and not willing to refrain from the use of any new vitamins and/or minerals and/or dietary and/or herbal supplements during the study.
12. Allergy or Significant history of hypersensitivity or idiosyncratic reactions to any investigational product or its excipients etc.
13. History of difficulty in swallowing.
14. Smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
15. Alcohol dependence, alcohol abuse, or drug abuse or addiction to any recreational drug within the past 6 months.
16. Significantly abnormal 12 lead ECG findings.
17. Participant with clinically significant abnormal laboratory values.
18. Patients deemed uncooperative or noncompliant.
19. Participation in another clinical trial within the preceding 90 days of the study starts.
20. Any other condition that the Principal Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The occurrence of adverse reactions
Change in vital signs, laboratory parameters |
Day 1 to Day 31
Screening to Day 31 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Mean change in serum Immunoglobulin IgG levels between groups
• Mean change in serum Immunoglobulin IgE levels between groups
• Mean change in lymphocyte: neutrophil ratio
• Mean change in Interleukin-6 (IL-6) level
• Mean change in high-sensitivity C-reactive protein (hsCRP) |
• Day 1 to Day 31
• Day 1 to Day 31
• Screening to Day 31.
• Day 1 to Day 31
• Day 1 to Day 31 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/01/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomized, Double-Blind, Placebo-Controlled, Two-arm, Parallel Study to Evaluate the Clinical Safety of Heat Inactivated Bacillus coagulans (Weizmannia coagulans) MTCC 5856 in Healthy Human Participants. Healthy male/non-pregnant, non-lactating female aged between 18 to 49 years will be enrolled in the study. Participants shall be randomized in a ratio of 1:1 into one of the two treatments. |