Safety of Streptococcus Salivarius inHealthy Individuals

Phase 3

Completed

• Registration Number: CTRI/2022/09/045368
• Lead Sponsor: nique Biotech Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-10-28
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1.Healthy adults of aged 18-65 years

2.Body mass index of 18.5-35 kg/m2

3.Normal or acceptable physical exam, vital signs and laboratory values

4.No known food allergies or intolerances

Exclusion Criteria

1.History of active or chronic dental or medical disease

2.Individuals who were prone to gas, bloating or diarrhoea

3.Pregnant or planning to become a pregnant, or breastfeeding

4.Received antibiotic treatment within last month or required to take antibiotics

during study period

5.Those who have used probiotic supplements with in last month or consumed

probiotic rich foods such as yogurt or kefir, used over-the-counter laxatives or

any other medications, supplements, or products that could have influenced the

endpoints in this study.

6.Those who are current users of tobacco products, vaping products, cannabis,

and/or nicotine replacement therapy

7.Individuals who are frequent users of alcohols

Study & Design

• Study Type: Interventional
• Study Design: Not specified