Text Size

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
History of Changes
  Purpose

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.


Condition Intervention
Recovery of Lactobacillus Reuteri ATCC PTA 4659
The Safety of Lactobacillus Reuteri ATCC PTA 4659
 Other: Probiotic strain ATCC PTA 4659

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Good Food Practice, Sweden:

Primary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Placebo control
Placebo control without probiotics 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: ATCC PTA 4659 Low dose 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: ATCC PTA 4659 high dose 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033539

Locations
Sweden
Good Food Practice
Uppsala, Sweden, 751 83
Sponsors and Collaborators
Good Food Practice, Sweden
Investigators
Principal Investigator: Birgitta E Sundberg, PhD Good Food Practice, Uppsala, Sweden
  More Information

No publications provided

Responsible Party: Good Food Practice, Sweden
ClinicalTrials.gov Identifier: NCT01033539     History of Changes
Other Study ID Numbers: CSP U-08-008 BSS
Study First Received: December 15, 2009
Last Updated: March 28, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Good Food Practice, Sweden:
Survive
safety
lactobacillus Reuteri

ClinicalTrials.gov processed this record on May 23, 2013