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

NCT ID: NCT01171014

Last Updated: 2010-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Gastrointestinal Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High dose probiotic

Bifidobacterium lactis HN019, 10 billion cfu/day

Group Type EXPERIMENTAL

Bifidobacterium lactis HN019

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days

Low dose probiotic

Bifidobacterium lactis HN019, 1 billion cfu/day

Group Type EXPERIMENTAL

Bifidobacterium lactis HN019

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo, once a day for 14 days

Interventions

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Bifidobacterium lactis HN019

Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium lactis HN019

Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo, once a day for 14 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danisco

INDUSTRY

Sponsor Role collaborator

Sprim Advanced Life Sciences

OTHER

Sponsor Role collaborator

Fonterra Research Centre

INDUSTRY

Sponsor Role lead

Responsible Party

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Fonterra Research Centre

Principal Investigators

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Philip Waller, MD

Role: PRINCIPAL_INVESTIGATOR

Accurate Clinical Research, Houston, TX

Other Identifiers

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#08-SPUS-o6-FON-01

Identifier Type: -

Identifier Source: org_study_id

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