Healthy Participants StudyNCT07377942
To Evaluate the Effect of Bacillus Subtilis Based Product in Gut Health and Immunomodulatory Effect in Healthy Adults.
A study testing Probiotics (Bacillus Subtilis) in people with Healthy Participants Study, run by Bioagile Therapeutics Pvt. Ltd. at 1 site in India.
Trial summary
The goal of this clinical trial is to Assess Gut Health and Immunomodulatory Effects of Bacillus Subtilis based product in Healthy Adults The main question[s] it aims to answer are to assess the effects of Bacillus Subtilis on gut health in healthy adults by measuring changes in fecal calprotectin levels as a marker… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study
- What is being tested?
- Probiotics (Bacillus Subtilis)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteIndia
- Study dates
- 16 Sep 2025to 10 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, aged between 18 and 50 years.
- 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.
- In good general health, as determined by medical history, laboratory analysis, and physical examination performed by the study physician.
- Willing to provide fecal samples as per the study requirements.
- Willing to participate voluntarily and provide written informed consent.
Who cannot join
- Women who are pregnant or lactating.
- Subjects who are taking Antibiotic treatment.
- Subjects suffering from Gastrointestinal disease.
- Subjects suffering from Diabetes.
- Subjects suffering from Chronic/iatrogenic Immunodeficiency.
- Subjects suffering from Abnormal blood pressure.
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- Subjects who are allergic to ingredients of the study Product.
- Subjects who are Smoker or alcoholic.
- Subjects who have participated prior in conflicting clinical trial or have participated in the trial over the last 3months.
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- Daily use of supplements that contain probiotics or prebiotics within 30 days prior to screening or during study.
- 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.
- Any surgical treatment within the previous three months or planned during the study.
- Any subject, in the principal investigator's opinion, not considered suitable for enrolment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing Gut Health and Immunomodulatory Effects of Bacillus Subtilis-based Product in Healthy Adults
The goal of this clinical trial is to Assess Gut Health and Immunomodulatory Effects of Bacillus Subtilis based product in Healthy Adults The main question[s] it aims to answer are to assess the effects of Bacillus Subtilis on gut health in healthy adults by measuring changes in fecal calprotectin levels as a marker of intestinal inflammation, in comparison between the intervention and placebo group.
To assess the immunomodulatory effects of Bacillus-Subtilis by measuring changes in inflammatory and immune response markers, in comparison between the intervention and placebo group To confirm the safety and tolerability of the study product Bacillus Subtilis in the healthy study population during the intended use, with safety assessments conducted across both the intervention and placebo groups.
Read more
The primary and secondary outcomes are:
Primary Efficacy Outcome:
- 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.
Secondary Efficacy Outcome:
- 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.
Participants will be asked to take the probiotics twice daily morning and evening after meals and record it in the subject diary.
- Conditions
- Healthy Participants Study
- Being tested
- Probiotics (Bacillus Subtilis), Placebo
- Keywords
- Gut Health and Immunomodulatory effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics (Bacillus Subtilis)Dietary supplement
Experimental
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Bacillus subtilis Receives: Dietary Supplement: Probiotics (Bacillus Subtilis) |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Change in fecal calprotectin levels from baseline to the end of the study.
Fecal calprotectin concentration (µg/g) will be measured at baseline and at the end of the study. The change from baseline will be analyzed.
Measured: Baseline to Week 8 (or end of study)
Secondary outcomes (5)
Change in Gut Health Status Questionnaire (GHSQ) Total Score from Baseline to End of Study
The Gut Health Status Questionnaire (GHSQ) total score will be assessed at baseline and at the end of the study. The change from baseline will be analyzed.
Measured: Baseline to Week 8 (End of Study)
Change in Serum Immunoglobulin A (IgA) Concentration from Baseline to End of Study
Serum IgA concentration (mg/dL) will be measured at baseline and at study completion, and the change from baseline will be assessed.
Measured: Baseline to Week 8 (or end of study)
Change in Serum Immunoglobulin G (IgG) Concentration from Baseline to End of Study
Serum IgG concentration (mg/dL) will be measured at baseline and at study completion, and the change from baseline will be assessed.
Measured: Baseline to Week 8 (or end of study)
Change in Serum Immunoglobulin M (IgM) Concentration from Baseline to End of Study
Serum IgM concentration (mg/dL) will be measured at baseline and at study completion, and the change from baseline will be assessed.
Measured: Baseline to Week 8 (or end of study)
Change in Immune Status Questionnaire (ISQ) Total Score from Baseline to End of Study
The Immune Status Questionnaire (ISQ) total score will be assessed at baseline and at the end of the study. The change from baseline will be analyzed.
Measured: Baseline to Week 8 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start16 Sep 2025
- Primary completion15 Apr 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioagile Therapeutics Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Parag Saudagar, Study director, S K Biobiz Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377942
- Sponsor's protocol ID
- BSP-25-072
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing Gut Health and Immunomodulatory Effects of Bacillus Subtilis-based Product in Healthy Adults
- ClinicalTrials.gov ID
- NCT07377942
- Acronym / sponsor ID
- BSP-25-072
- Conditions
- Healthy Participants Study
- Keywords
- Gut Health and Immunomodulatory effect
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Bioagile Therapeutics Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to Assess Gut Health and Immunomodulatory Effects of Bacillus Subtilis based product in Healthy Adults The main question[s] it aims to answer are to assess the effects of Bacillus Subtilis on gut health in healthy adults by measuring changes in fecal calprotectin levels as a marker of intestinal inflammation, in comparison between the intervention and placebo group.
To assess the immunomodulatory effects of Bacillus-Subtilis by measuring changes in inflammatory and immune response markers, in comparison between the intervention and placebo group To confirm the safety and tolerability of the study product Bacillus Subtilis in the healthy study population during the intended use, with safety assessments conducted across both the intervention and placebo groups.
The primary and secondary outcomes are:
Primary Efficacy Outcome:
- 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.
Secondary Efficacy Outcome:
- 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.
Participants will be asked to take the probiotics twice daily morning and evening after meals and record it in the subject diary.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Probiotics (Bacillus Subtilis)Bacillus subtilis |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female, aged between 18 and 50 years.
- 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.
- In good general health, as determined by medical history, laboratory analysis, and physical examination performed by the study physician.
- Willing to provide fecal samples as per the study requirements.
- Willing to participate voluntarily and provide written informed consent.
Key exclusion criteria (14 listed)
- Women who are pregnant or lactating.
- Subjects who are taking Antibiotic treatment.
- Subjects suffering from Gastrointestinal disease.
- Subjects suffering from Diabetes.
- Subjects suffering from Chronic/iatrogenic Immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics (Bacillus Subtilis)Experimental | Dietary supplement | Probiotics |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
• Change in fecal calprotectin levels from baseline to the end of the study.
Time frame: Baseline to Week 8 (or end of study)
Fecal calprotectin concentration (µg/g) will be measured at baseline and at the end of the study. The change from baseline will be analyzed.
5 secondary outcomes
Change in Gut Health Status Questionnaire (GHSQ) Total Score from Baseline to End of Study
Time frame: Baseline to Week 8 (End of Study)
Change in Serum Immunoglobulin A (IgA) Concentration from Baseline to End of Study
Time frame: Baseline to Week 8 (or end of study)
Change in Serum Immunoglobulin G (IgG) Concentration from Baseline to End of Study
Time frame: Baseline to Week 8 (or end of study)
Change in Serum Immunoglobulin M (IgM) Concentration from Baseline to End of Study
Time frame: Baseline to Week 8 (or end of study)
Change in Immune Status Questionnaire (ISQ) Total Score from Baseline to End of Study
Time frame: Baseline to Week 8 (End of Study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Parag Saudagar study director
S K Biobiz Private Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics (Bacillus Subtilis) in people with Healthy Participants Study, run by Bioagile Therapeutics Pvt. Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Change in fecal calprotectin levels from baseline to the end of the study. (time frame: Baseline to Week 8 (or end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.