Good Food Practice
Uppsala, Uppsala County, 751 83, Sweden
Completed
NCT Number: NCT01033539
To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans
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.
Completed
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Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Probiotic strain ATCC PTA 4659
OtherPlacebo 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
Other names: ATCC PTA 4659
Primary outcomes
-
Change form baseline to day 28 on treatment in level of live Lactobacillus Reuteri ATC PTA 4659 in faecal material.
Time frame: Nov 2009-April2010
Sponsors and collaborators
Lead sponsor
Good Food Practice, Sweden
Industry
Registry information
Important dates
- Study start
- 2009
- Primary completion
- 2010
- Study completion
- 2011
- First posted
- Dec 16, 2009
- Registry last updated
- Mar 29, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.