NCT04044144

Prospective Tolerability Assessment of a Probiotic Dietary Supplement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Metagenics, Inc. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Each of the strains in the formula have previously been studied in human subjects, including several clinical populations. However, the present eight strain combination formula has not previously been evaluated in human subjects. This prospective study will evaluate the tolerability of the eight strain formula in healthy adults.

Detailed description

Background \& Significance: The dietary supplement being investigated is a formula containing a combination of eight probiotic strains. The combination formula was developed to support general gastrointestinal and immune health. Each of the strains in the formula have previously been studied in human subjects, including several clinical populations. However, the present eight strain combination formula has not previously been evaluated in human subjects. Research Design \& Methods: This prospective study will evaluate the tolerability of the eight strain formula in healthy adults over a 10-day period. The primary aim of the study is to assess tolerability as determined by the frequency of study participants who withdraw from the study due to adverse events.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic Dietary Supplement	Dietary supplement containing a combination of 8 probiotic strains

Timeline

• Start date: 2019-08-12
• Primary completion: 2019-08-23
• Completion: 2019-08-23
• First posted: 2019-08-05
• Last updated: 2022-04-06

Locations

1 site across 1 country: United States