NCT01568567

Study to Demonstrate the Safety of a Novel Powder Formulation of Lactobacilli in Adults

To Demonstrate That a Novel Powder Formulation of Lactobacillus Reuteri DSM 17938 is Safe in Adults, a Randomized, Placebo Controlled Double-blind Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Good Food Practice, Sweden · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Lactobacilli are commensal bacteria common to the gut of all mammals studied and traditionally associated with foods are considered safe.The established safe use on a diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as well as adults. Although the tolerability of DSM 17938 in a tablet formulation has earlier been established, it is desirable to repeat the assessment in this novel formulation.

Conditions

• Safety

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus Reuteri DSM 17938	One stick pack in the morning and one stick pack afternoon/evening for 28 days.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-04-02
• Last updated: 2012-07-04

Locations

1 site across 1 country: Sweden