Trial | NCT01033539  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

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

  • Study Participants

    30
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.
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 Started
Nov 30
2009
Primary Completion
Apr 30
2010
Study Completion
Aug 31
2011
Last Update
Mar 29
2012
Estimate

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

  • Other names: ATCC PTA 4659

Placebo control Active Comparator

Placebo control without probiotics ATCC PTA 4659

ATCC PTA 4659 Low dose Active Comparator

ATCC PTA 4659 high dose Active Comparator

Criteria 

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
No Results Posted