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NCT01171014 Clinical Trial

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

Gastrointestinal Symptoms Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01171014
Other study ID # #08-SPUS-o6-FON-01
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received July 26, 2010
Last updated July 27, 2010
Start date June 2009
Est. completion date December 2009

Study information
Verified date July 2010
Source Fonterra Research Centre
Contact n/a
Is FDA regulated No
Health authority New Zealand: Food Safety Authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Bifidobacterium lactis HN019
Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days
• Bifidobacterium lactis HN019
Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days
• Placebo
Placebo, once a day for 14 days

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Fonterra Research Centre Danisco, Sprim Advanced Life Sciences

Outcome
Type Measure Description Time frame Safety issue
Primary Colonic transit time 14 days No
Secondary Gastrointestinal symptoms 14 days No
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