None listed
Conditions
Interventions
Intervention1: Lactic Acid Bacteria (LAB): Strain: Lactobacillus fermentum HEM792
Category: Probiotic
Strain will be present at a dose of 1 10 CFU (100 billion CFU/person/day).
Control Interventi
Sponsors
AceOne Rs
Eligibility
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Visit 1 (Day 1) Visit 2 (Day 30 2 Days) Visit 3 (Day 60 2 Days) Visit 4 (Day 90 2 Days)(EOT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include assessment of product tolerability, changes in vital signs, and overall health-related quality of life using the SF-36v2 questionnaire.Timepoint: Visit 1 (Day 1) Visit 2 (Day 30 2 Days) Visit 3 (Day 60 2 Days) Visit 4 (Day 90 2 Days)(EOT) | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
SAMAHITHA RESEARCH SOLUTIONS
Outcome results
None listed