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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Good Food Practice, Sweden
ClinicalTrials.gov Identifier:
NCT01033539
First received: December 15, 2009
Last updated: March 28, 2012
Last verified: March 2012

December 15, 2009
March 28, 2012
November 2009
April 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01033539 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
  • Recovery of Lactobacillus Reuteri ATCC PTA 4659
  • The Safety of Lactobacillus Reuteri ATCC PTA 4659
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 Name: ATCC PTA 4659
  • Active Comparator: Placebo control
    Placebo control without probiotics ATCC PTA 4659
    Intervention: Other: Probiotic strain ATCC PTA 4659
  • Active Comparator: ATCC PTA 4659 Low dose
    Intervention: Other: Probiotic strain ATCC PTA 4659
  • Active Comparator: ATCC PTA 4659 high dose
    Intervention: Other: Probiotic strain ATCC PTA 4659
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2011
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01033539
CSP U-08-008 BSS
No
Good Food Practice, Sweden
Good Food Practice, Sweden
Not Provided
Principal Investigator: Birgitta E Sundberg, PhD Good Food Practice, Uppsala, Sweden
Good Food Practice, Sweden
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP