Safety of Streptococcus Salivarius in Healthy Individuals

A Prospective, Block Randomized, Double-Blind Placebo-Controlled Study to Study the Safety Profile of Streptococcus Salivarius UBSS-01 in Healthy Individuals

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045368

Enrollment

Registered

2022-09-09

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

None listed

Interventions

Intervention1: Streptococcus Salivarius UBSS-01: Each sachet contain of Streptococcus Salivarius UBSS-01 contains 10 billion colony-forming units-once a day at night for 30 days Control Intervention1

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Incidences of adverse events (AE) in the Streptococcus salivarius UBSS-01 and placebo group during the treatment.Timepoint: Day 1 to Day 30	—

Secondary

Measure	Time frame
medication compliances of Streptococcus salivarius UBSS-01 as a probiotic candidate in healthy individuals.Timepoint: Day 1 to Day 30	—

Countries

India

Contacts

Public ContactDr Jayanthi

Adichunchanagiri University

rajeshvenky_research@hotmail.com9980038331

Outcome results