Effect of Bifidobacterium Lactis HN019 on Colonic Transit Time and Digestive Symptoms

July 27, 2010 updated by: Fonterra Research Centre

A Three-Arm, Placebo Controlled, Double-Blind, Single Center Study to Evaluate the Impact of Probiotic Strain Bifidobacterium Lactis HN019 on Intestinal Well-Being, Colonic Transit Time and Digestive Discomfort

The purpose of this study was to investigate the dose response effect of Bifidobacterium lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

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

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy males and females aged 25 to 65 years
  • stool type 2-4 on the Bristol Stool Chart
  • 1 to 3 bowel movements per week

Exclusion Criteria:

  • use of any probiotic product intended to improve gastrointestinal function within the 2 weeks preceding study entry
  • major chronic and uncontrolled systemic medical conditions
  • severe gastrointestinal conditions known to prolong CTT
  • lactose intolerance
  • chronic diarrhea
  • gastric bypass surgery or lap band insertion for weight loss
  • regular laxative use
  • pregnant or breast-feeding women

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo, once a day for 14 days
Experimental: High dose probiotic
Bifidobacterium lactis HN019, 10 billion cfu/day
Dietary supplement: Bifidobacterium lactis HN019
Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days
Dietary supplement: Bifidobacterium lactis HN019
Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days
Experimental: Low dose probiotic
Bifidobacterium lactis HN019, 1 billion cfu/day
Dietary supplement: Bifidobacterium lactis HN019
Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days
Dietary supplement: Bifidobacterium lactis HN019
Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Colonic transit time
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Gastrointestinal symptoms
Time Frame: 14 days
14 days

Collaborators and Investigators

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

Sponsor

Fonterra Research Centre

Collaborators

Sprim Advanced Life Sciences
Danisco

Investigators

  • Principal Investigator: Philip Waller, MD, Accurate Clinical Research, Houston, TX

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

June 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

July 26, 2010

First Submitted That Met QC Criteria

July 27, 2010

First Posted (Estimate)

July 28, 2010

Study Record Updates

Last Update Posted (Estimate)

July 28, 2010

Last Update Submitted That Met QC Criteria

July 27, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • #08-SPUS-o6-FON-01

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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