NCT01033539

To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Good Food Practice, Sweden · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the effects of a sachet containing Lactobacillus Reuteri ATCC PTA 4659 on the recovery of live Lactobacillus reuteri in fecal samples after 7, 14 and 28 days supplementation as well as 14 days wash out compared to the same sachet without the probiotic bacteria as placebo control.

Detailed description

This study is the first to investigate the relative colonisation of the human GI tract by L Reuteri ATCC PTA 4659. Simple demonstration that they survive passage is the first step in development of potential new probiotics, which is necessary before these strains can be considered for continued testing in probiotic food matrices. The aim of this study will evaluate the safety and tolerability of Lactobacillus Reuteri in healthy adult subjects.

Conditions

• Recovery of Lactobacillus Reuteri ATCC PTA 4659
• The Safety of Lactobacillus Reuteri ATCC PTA 4659

Interventions

Type	Name	Description
OTHER	Probiotic strain ATCC PTA 4659	Placebo control containing no probiotic strain of ATCC PTA 4659 High dose of ATCC PTA 4659 1\*10 10 CFU/bag Low dose of ATCC PTA 4659 1\*10 8 CFU/bag

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-04-01
• Completion: 2011-08-01
• First posted: 2009-12-16
• Last updated: 2012-03-29

Locations

1 site across 1 country: Sweden