| CTRI Number |
CTRI/2026/02/103711 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
29/05/2026 |
| 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
|
A Study to Check the Safety of Two Probiotic Products Compared to a Dummy Product in Healthy Children. |
|
Scientific Title of Study
|
A Prospective, Double-Blind, Three-Arm, Placebo-Controlled, single-Centre, Comparative Clinical Study to Evaluate the Safety Profile of Probiotic Mixture A (2 Strains) and Probiotic Mixture B (2 Strains) in Healthy Children. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2601 Version No.: 1.0 Date: 07 Jan 2026 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sharmili Ugraiah |
| Designation |
Principal Investigator |
| Affiliation |
Currex Hospital |
| Address |
No. 55 56, Seegehalli Main Road, Bhoo Samartha Layout, Seegehalli KS Halli, Bengaluru, Karnataka India
Bangalore
KARNATAKA
560049
India |
| Phone |
07899461922 |
| Fax |
|
| Email |
drsharmili1010@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 |
09739001749 |
| 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 |
06364898825 |
| Fax |
|
| Email |
mamatha@samahitha.com |
|
|
Source of Monetary or Material Support
|
| AceOne Rs, AceOne Rs, Suite 313, 14631 Route 29,
Centreville, VA 20111, USA |
|
|
Primary Sponsor
|
| Name |
AceOne Rs |
| Address |
AceOne Rs, 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 |
| DrSharmili Ugraiah |
Currex Hospital |
No. 55 56, Seegehalli Main Road, Bhoo Samartha Layout, Seegehalli KS Halli, Bengaluru, Karnataka India
Bangalore
KARNATAKA |
07899461922
drsharmili1010@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Comparator Agent |
Placebo |
An inert, organoleptically matched powder/sachet containing excipients only, without viable microorganisms |
| Intervention |
Probiotic Mixture A (L. plantarum and L. fermentum HEM 1036)
Probiotic Mixture B (L. rhamnosus and L. paracasei) |
A combination of the following two lactic acid bacteria (LAB) strains:
-Lactobacillus plantarum
-Lactobacillus fermentum HEM 1036
Each strain will be present at a dose of 1 × 10¹¹ CFU (100 billion CFU/person/day), providing a total daily dose of 2 × 10¹¹ CFU (200 billion CFU/person/day). |
| Intervention |
Probiotic Mixture B (L. rhamnosus and L. paracasei) |
A combination of the following two lactic acid bacteria (LAB) strains:
-Lactobacillus rhamnosus
-Lactobacillus paracasei
Each strain will be present at a dose of 1 × 10¹¹ CFU (100 billion CFU/person/day), providing a total daily dose of 2 × 10¹¹ CFU (200 billion CFU/person/day). |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
-Healthy children aged 2 to 8 years
-Assessed as healthy based on medical history physical examination vital signs and laboratory tests
-Parent or legal guardian able to provide written informed consent before any study procedures
-Parent or legal guardian willing to follow the study protocol
-Parent or legal guardian agrees to maintain a participant diary and report any adverse events during the study
|
|
| ExclusionCriteria |
| Details |
-Participation in any other clinical trial or use of an investigational product within 90 days prior to screening
-Known allergy or hypersensitivity to any component of the study product or placebo
-History or presence of any significant medical condition including gastrointestinal hepatic renal metabolic cardiovascular neurological or immunological disorders that may affect study participation or safety
-History of psychiatric illness
-Acute illness infection or fever at the time of screening
-Abnormal laboratory values at screening considered clinically significant by the Investigator
-Use of antibiotics probiotics prebiotics or synbiotics within 14 days prior to screening
-Children receiving long term medication that may interfere with study outcomes
-Any other condition or circumstance that in the opinion of the Investigator makes the child unsuitable for the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Safety of the investigational products assessed by the incidence nature severity and relationship of treatment emergent adverse events and serious adverse events from baseline to the end of the study
-Changes in clinical laboratory safety parameters from baseline to end of treatment including
-Complete Blood Count
-Liver Function Tests
-Renal Function Tests
-Fasting Blood Glucose
-Lipid Profile
-Urinalysis
|
Visit 1 (Day 1)
Visit 2 (Day 30±2 Days)
Visit 3 (Day 60±2 Days)
Visit 4 (Day 90±2 Days)(EOT/S)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Tolerability of the investigational products assessed throughout the study based on feeding behaviour and parent or legally acceptable guardian reported acceptability
-Changes in vital signs including temperature heart rate and respiratory rate from baseline to each follow up visit and end of treatment
-Compliance with study product administration assessed through study product accountability and participant diary review
|
Visit 1 (Day 1)
Visit 2 (Day 30±2 Days)
Visit 3 (Day 60±2 Days)
Visit 4 (Day 90±2 Days)(EOT/S)
|
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
Modification(s)
|
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
|
This is a prospective, randomized, double-blind, placebo-controlled, Single-centre clinical study designed to evaluate and compare the safety and tolerability of two high-dose, multi-strain probiotic mixtures in healthy children aged 2 to 8 years. The study will assess Probiotic Mixture A and Probiotic Mixture B, each containing two well-known lactic acid bacteria strains, administered at a daily dose of 200 billion CFU, against a placebo. Safety will be evaluated over a 90-day period through monitoring of adverse events, laboratory parameters, vital signs, and parent-reported tolerability. The study aims to generate robust clinical safety data to support the safe use of probiotic formulations in pediatric populations. |