Recovery of Lactobacillus Reuteri ATCC PTA 4659, The Safety of Lactobacillus Reuteri ATCC PTA 4659
Conditions
Keywords
Survive, safety, lactobacillus Reuteri
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.
Interventions
OTHERProbiotic 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
Sponsors
Good Food Practice, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
Sweden
Outcome results
None listed