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

Not Applicable

Completed

• Conditions: Recovery of Lactobacillus Reuteri ATCC PTA 4659; The Safety of Lactobacillus Reuteri ATCC PTA 4659
• Interventions: Other: Probiotic strain ATCC PTA 4659

• Registration Number: NCT01033539
• Lead Sponsor: Good Food Practice, Sweden

Brief 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Primary Completion: 2010-04
• Study Completion: 2011-08
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Males and females
• Age 18-65 years
• BMI 19-33
• Hb 120 g/women 130 g/l for men
• Healthy assessed by screening tests and physical examination
• Signed informed consent and bio bank consent

Exclusion Criteria

• Participation in a clinical study within 90 days prior screening use of antibiotics 2 weeks before baseline
• Pregnant or lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo control	Probiotic strain ATCC PTA 4659	Placebo control without probiotics ATCC PTA 4659
ATCC PTA 4659 Low dose	Probiotic strain ATCC PTA 4659	-
ATCC PTA 4659 high dose	Probiotic strain ATCC PTA 4659	-

Primary Outcome Measures

Name	Time	Method
Change form baseline to day 28 on treatment in level of live Lactobacillus Reuteri ATC PTA 4659 in faecal material.	Nov 2009-April2010

Trial Locations

Locations (1)

Good Food Practice; 🇸🇪 Uppsala, Sweden