| CTRI Number |
CTRI/2026/02/103709 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A Clinical Study to Evaluate the Safety of a Probiotic Supplement in Healthy Adults |
Scientific Title of Study
Modification(s)
|
A Prospective Double Blind Two Arm Placebo Controlled Single Centre Clinical Study to Evaluate the Safety of Lactic Acid Bacteria Lactobacillus fermentum HEM792 in Healthy Adults |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CTSRS/2602 Version No:2.0 Dated 26 Feb 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjunath U |
| Designation |
Principal Investigator |
| Affiliation |
Currex Hospital |
| Address |
No. 55 56, Seegehalli Main Road, Bhoo Samartha Layout, Seegehalli KS Halli, Bengaluru, Karnataka India
Bangalore
KARNATAKA
560059
India |
| Phone |
9900282899 |
| Fax |
|
| Email |
drmanju1910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi LM |
| Designation |
HOD Clinical Operations |
| Affiliation |
SAMAHITHA RESEARCH SOLUTIONS |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore.
Bangalore
KARNATAKA
560069
India |
| Phone |
9739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Mamatha B Gokavi |
| Designation |
Project Manger |
| Affiliation |
SAMAHITHA RESEARCH SOLUTIONS |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore.
Bangalore
KARNATAKA
560069
India |
| Phone |
09739001749 |
| Fax |
|
| Email |
mamatha@samahitha.com |
|
|
Source of Monetary or Material Support
|
| AceOne Rs,Suite 313, 14631 Route 29,
Centreville, VA 20111, USA |
|
|
Primary Sponsor
|
| Name |
AceOne Rs |
| Address |
Suite 313, 14631 Route 29,
Centreville, VA 20111, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Manjunath U |
Currex Hospital |
No.55 56, Seegehalli Main Road, Bhoo Samartha layout, Seegehalli, KS Halli, Bengaluru, Karnataka
Bangalore
KARNATAKA |
9900282899
drmanju1910@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Safety |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lactic Acid Bacteria (LAB) |
Strain: Lactobacillus fermentum HEM792
Category: Probiotic
Strain will be present at a dose of 1 × 10¹¹ CFU (100 billion CFU/person/day).
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
-Eligible participants must meet all of the following criteria
-Healthy adults of both genders aged 19 to 75 years
-Able and willing to provide written informed consent before any study related procedures
-Willing to follow the study requirements including scheduled visits laboratory tests and use of the study product
-Able and willing to maintain a participant diary to record daily product intake tolerability and any adverse events
-Participants with clinical laboratory values at screening that are within normal limits or considered acceptable by the investigator
|
|
| ExclusionCriteria |
| Details |
-Participation in another clinical trial within the past 3 months
-History of psychiatric illness or any condition that may affect study compliance
-Known allergy or intolerance to probiotics or any component of the study product
-Current use of investigational products probiotic supplements or probiotic rich foods that cannot be stopped during the study period
-Any clinically significant medical condition or abnormal laboratory value that in the opinion of the investigator may increase risk or affect study assessments
-Pregnant or breastfeeding women
-Participants who are immunocompromised have chronic infections or are receiving immunosuppressive therapy
-Any other condition that in the opinion of the investigator makes the participant unsuitable for the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety of the investigational product will be assessed through treatment-emergent and serious adverse events, as well as changes in laboratory parameters including CBC, LFT, RFT, fasting blood glucose, lipid profile, and urinalysis. |
Visit 1 (Day 1)
Visit 2 (Day 30±2 Days)
Visit 3 (Day 60±2 Days)
Visit 4 (Day 90±2 Days)(EOT)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary endpoints include assessment of product tolerability, changes in vital signs, and overall health-related quality of life using the SF-36v2 questionnaire. |
Visit 1 (Day 1)
Visit 2 (Day 30±2 Days)
Visit 3 (Day 60±2 Days)
Visit 4 (Day 90±2 Days)(EOT)
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
23/02/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a prospective, open-label, single-arm, single-centre clinical study designed to evaluate the safety and tolerability of the probiotic strain Lactobacillus fermentum HEM792 in healthy adults. L. fermentum is a naturally occurring beneficial bacterium commonly found in the human gut and fermented foods, with recognized probiotic properties such as supporting gut health, immune function, and antioxidant activity. While Lactobacillus species are generally considered safe, this study will specifically assess the safety of high-dose administration (100 billion CFU per day). Safety will be evaluated through monitoring of adverse events, vital signs, and laboratory parameters to generate robust clinical data supporting its use in healthy adult populations. |