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

NCT01033539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-03-29

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Good Food Practice, Sweden

    lead INDUSTRY

Principal Investigators

  • Birgitta E Sundberg, PhD · Good Food Practice, Uppsala, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-04-30
Completion
2011-08-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01033539 on ClinicalTrials.gov