A Study to Check the Safety of Two Probiotic Products Compared to a Dummy Product in Healthy Children.

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. - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/103711

Enrollment

180

Registered

2026-02-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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:

Eligibility

Inclusion criteria

Inclusion criteria: -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

Exclusion criteria

Exclusion criteria: -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

Design outcomes

Primary

Measure	Time frame
-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 Timepoint: Visit 1 (Day 1) Visit 2 (Day 30Â±2 Days) Visit 3 (Day 60Â±2 Days) Visit 4 (Day 90Â±2 Days)(EOT/S)	—

Measure

Time frame

-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 Timepoint: Visit 1 (Day 1) Visit 2 (Day 30Â±2 Days) Visit 3 (Day 60Â±2 Days) Visit 4 (Day 90Â±2 Days)(EOT/S)

—

Secondary

Measure	Time frame
-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 Timepoint: Visit 1 (Day 1) Visit 2 (Day 30Â±2 Days) Visit 3 (Day 60Â±2 Days) Visit 4 (Day 90Â±2 Days)(EOT/S)	—

Measure

Time frame

-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 Timepoint: Visit 1 (Day 1) Visit 2 (Day 30Â±2 Days) Visit 3 (Day 60Â±2 Days) Visit 4 (Day 90Â±2 Days)(EOT/S)

—

Countries

India

Contacts

Public ContactMs Mamatha B Gokavi

SAMAHITHA RESEARCH SOLUTIONS

satyalm@samahitha.com09739001749

Outcome results