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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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