| CTRI Number |
CTRI/2025/07/090157 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of bacillus subtilis based product in Gut Health and Immunomodulatory effect in healthy adults. |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-blinded, Placebo-controlled Parallel Group-Clinical trial Assessing Gut Health and Immunomodulatory Effects of Bacillus Subtilis based product in Healthy Adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BSP-25-072 [Version 1.0, dated 17 April 2025] |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinay BN |
| Designation |
Principal Investigator |
| Affiliation |
Advanced Gastro Care |
| Address |
Advanced Gastro Care
176/1, 6th Cross Road, 4th Main Road, Landmark: Near Sri Sidda Road Vidya Pita Primary School, Bengaluru
Bangalore KARNATAKA 560018 India |
| Phone |
9972121844 |
| Fax |
|
| Email |
vinaybndoc@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
BioAgile Therapeutics Private Limited |
| Address |
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road RMV 2nd Stage, Bengaluru 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 Private Limited |
| Address |
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road RMV 2nd Stage, Bengaluru 560094, India
Bangalore KARNATAKA 560094 India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
|
Source of Monetary or Material Support
|
| S K Biobiz Pvt Ltd, Unit I, G1-G5, Sancheti Ware housing Complex, 10th Mile, Mumbai Agra Road, Jaulke, Tal. Dindori, Nashik 422206. Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
S K Biobiz Pvt Ltd |
| Address |
Unit I, G1-G5, Sancheti Ware housing Complex, 10th Mile, Mumbai Agra Road, Jaulke, Tal. Dindori, Nashik-422206. Maharashtra, India. |
| Type of Sponsor |
Other [Biotechnology Company] |
|
|
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 Vinay BN |
Advanced Gastro Care |
Advanced Gastro Care
176/1, 6th Cross Road, 4th Main Road, Landmark: Near Sri Sidda Road Vidya Pita Primary School, Bangalore Bangalore KARNATAKA |
9972121844
vinaybndoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Monitoring Immune markers and gut health in healthy human volunteers. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SKB 101 (White crystalline free flowing Powder) |
Twice a day for 60 days |
| Intervention |
SKB_BS2074 (Bacillus subtilis 2×109 cfu/g) White crystalline free flowing Powder |
twice a day for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female, aged between 18 and 50 years.
2.Female participants are either not of childbearing potential, or females of childbearing potential agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
3.In good general health, as determined by medical history, laboratory analysis, and physical examination performed by the study physician.
4.Willing to provide fecal samples as per the study requirements.
5.Willing to participate voluntarily and provide written informed consent. |
|
| 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 Smoker or alcoholic.
9.Subjects who have participated prior in conflicting clinical trial or have participated in the trial over the last 3months.
10.Women who are pregnant, breastfeeding, or planning to become pregnant.
11.Daily use of supplements that contain probiotics or prebiotics within 30 days prior to screening or during study.
12.Subjects with medical conditions affecting immune status e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV or taking medications that may impact the immune system, such as antibiotics, antimicrobials, or probiotic sachets.
13.Any surgical treatment within the previous three months or planned during the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Change in fecal calprotectin levels from baseline to the end of the study, comparing the intervention and placebo groups.
•Changes in immunological markers (IgA, IgG, IgM) between baseline and study completion, comparing the intervention and placebo groups.
•Improvement in the patient related overall relief, assessed using Gut Health Status Questionnaire (GHSQ) and Immune status questionnaire (ISQ) score with comparative analysis between the two groups.
|
Day 0; Day 30; Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Incidence of adverse events (AEs) and serious adverse events (SAEs) throughout the study duration, compared between the intervention and placebo groups.
•Changes in vital signs, laboratory parameters, and physical examination findings from baseline to the end of the study, analysed for differences between groups.
|
Day 0; Day 30; Day 60 |
|
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Probiotics interact with gut-associated lymphoid tissue (GALT) to stimulate immune cells and cytokine production. They improve gut health, reduce allergic reactions, and enhance the body’s ability to fight infections. Probiotics have shown potential in managing conditions like inflammatory bowel disease (IBD), allergies, and even some autoimmune disorders. The Bacillus family contains many important probiotic species, including bacillus coagulans, bacillus subtilis, and bacillus clausii — all of which show significant success in reducing digestive complaints. Bacillus subtilis in particular has been shown to help reduce symptoms of IBS and other gastrointestinal disorders, restore microbial balance in the gut, and reduce inflammation within the gastrointestinal tract. Historically, Bacillus species have been used for their antimicrobial effects and in the fermentation of foods. More recently, they’ve been used for many types of GI ailments, including irritable bowel syndrome, while healing underlying inflammation and disturbance in the gut microbiota. Soil-based microorganisms can successfully help fight the effects of certain bad bacteria in the GI tract, such as C. difficile infection and H. pylori — especially when used alongside conventional antibiotic theraphy. Their capability in combating these pathogens, along with their ability to colonize the GI tract, helps them to effectively restore the natural microbe in the gastrointestinal tract |