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

Phase 2

Completed

• Conditions: Gastrointestinal Symptoms
• Interventions: Dietary Supplement: Bifidobacterium lactis HN019; Dietary Supplement: Placebo

• Registration Number: NCT01171014
• Lead Sponsor: Fonterra Research Centre

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-07
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-27
• Last Update Submitted: 2010-07-27
• Study First Posted: 2010-07-28
• Last Update Posted: 2010-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose probiotic	Bifidobacterium lactis HN019	Bifidobacterium lactis HN019, 10 billion cfu/day
Low dose probiotic	Bifidobacterium lactis HN019	Bifidobacterium lactis HN019, 1 billion cfu/day
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Colonic transit time	14 days

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms	14 days