NCT05044949

Study Evaluating the Safety and Tolerability of a Probioitc

A Double-blind, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Safety and Tolerability of Limosilactobacillus Reuteri Administered to Healthy Volunteers.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: BioGaia AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The rationale for the current study is to initially evaluate the safety and tolerability of a novel strain of the probiotic Limosilactobacillus reuteri (L. reuteri) in healthy volunteers.

Detailed description

Probiotics are live microorganisms, which when administered in adequate amounts, confer a health benefit on the host. Probiotics have been studied for decades for their potential health benefits of non-pathogenic microorganisms. The species Limosilactobacillus reuteri (L. reuteri), formerly Lactobacillus reuteri, is currently used in probiotic products. The design of the study is based on the aim to study the safety and tolerability of a novel strain of the probiotic Limosilactobacillus reuteri (L. reuteri) in a limited number of healthy volunteers.

Conditions

• Healthy Volunteers
• Tolerability
• Safety

Interventions

Type	Name	Description
OTHER	Probiotic	The study product is a probiotic strain
OTHER	Placebo	The study product is a placebo to the probiotic strain

Timeline

• Start date: 2021-11-01
• Primary completion: 2021-12-31
• Completion: 2022-01-20
• First posted: 2021-09-16
• Last updated: 2022-02-11

Locations

2 sites across 1 country: Sweden