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

March 28, 2012 updated by: Good Food Practice, Sweden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 751 83
        • Good Food Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • ATCC PTA 4659

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Nov 2009-April2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Good Food Practice, Sweden

Investigators

  • Principal Investigator: Birgitta E Sundberg, PhD, Good Food Practice, Uppsala, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (Estimate)

December 16, 2009

Study Record Updates

Last Update Posted (Estimate)

March 29, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CSP U-08-008 BSS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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