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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Recovery of Lactobacillus Reuteri ATCC PTA 4659, The Safety of Lactobacillus Reuteri ATCC PTA 4659

Intervention / Treatment
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* Other: Probiotic strain ATCC PTA 4659


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo control<br>Placebo control without probiotics ATCC PTA 4659 | Other: Probiotic strain ATCC PTA 4659<br>* 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<br>* Other names: ATCC PTA 4659;|
| Active Comparator: ATCC PTA 4659 Low dose<br> | Other: Probiotic strain ATCC PTA 4659<br>* 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<br>* Other names: ATCC PTA 4659;|
| Active Comparator: ATCC PTA 4659 high dose<br> | Other: Probiotic strain ATCC PTA 4659<br>* 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<br>* Other names: ATCC PTA 4659;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change form baseline to day 28 on treatment in level of live Lactobacillus Reuteri ATC PTA 4659 in faecal material. |  | Nov 2009-April2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Survive, safety, lactobacillus Reuteri