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CTRI Number  CTRI/2025/07/090064 [Registered on: 02/07/2025] 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 Coagulans 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 Coagulans based product in Healthy Adults.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
BSP-25-073 [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, Bangalore

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, RMV 2nd stage, 80 feet road, bangalore 560094, Karnataka, 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, RMV 2nd stage, 80 feet road, bangalore 560094, Karnataka, India


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  Parag Saudagar 
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 560018
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  Not Applicable  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  SKB 101 (White crystalline free flowing Powder)   Dose: 1g of Powder Frequency: Twice a day (Morning and Evening) Route of administration: Mix with 10ml of water and taken it orally. Duration: 60 days  
Intervention  SKB_Lab19(Bacillus coagulans 2×109 cfu/g) White crystalline free flowing Powder   Dose: 1g Of Powder Frequency: Twice a day (Morning and evening) Route of administration: Mix it with 10ml of water and taken it Orally. Duration: 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.


 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Change in fecal calprotectin levels from baseline to the end of the study, comparing the intervention and placebo groups.



2. Changes in immunological markers (IgA, IgG, IgM) between baseline and study completion, comparing the intervention and placebo groups.

3. 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 
1. Incidence of adverse events AEs & serious adverse events SAEs throughout the study duration, compared between the intervention & placebo groups.
2. Changes in vital signs, laboratory parameters, & physical examination findings from baseline to the end of the study, analyzed 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)= "46"
Final Enrollment numbers achieved (India)="46" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   30/07/2025 
Date of Study Completion (India) 01/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Human beings consume a significant number of pathogens every day, primarily bacteria. For several decades, probiotic microorganisms have been utilized in several diets due to their positive effects on human health. The Agriculture Organization of the United States and the World Health Organization defined probiotics in 2001 as bacteria that, when given to a host at adequate levels, improve their health. Regarding probiotics, Lactobacillus and Bifidobacterium are the two most frequently used genera. These bacteria are generally thought of as harmless due to their ability to survive in the body to cure and prevent diseases, unlike the usual pathogens. Along with that, these microorganisms have played a vital role in the process of fermenting milk and food preservation for many years. B. coagulans is a Gram-positive, spore-forming, and motile bacterium. The optimum growth temperature ranges from 35 to 50 °C. The optimum growth pH is 5.5-6.5. The bacteria are facultative anaerobic, and ferment maltose, mannitol, raffinose, sucrose and trehalose with production of acid but not gas. Due to the large amount of lactic acid produced in metabolism, B. coagulans is frequently reported to cause spoilage of dairy products, vegetables or fruits. The spores of B. coagulans can resist gastric acid to reach the small intestine, where they can germinate and propagate. The average time from oral administration to germination is 4-6 h. Approximately 85% of the spores reach the intestine. After a single oral administration, B. coagulans is excreted in faeces for about 7 days. Therefore, in order to achieve long-term treatment, the spores of B. coagulans must be orally ingested daily. 
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