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

This study has been completed.
Sponsor:
Collaborators:
Danisco
Sprim Advanced Life Sciences
Information provided by:
Fonterra Research Centre
ClinicalTrials.gov Identifier:
NCT01171014
First received: July 26, 2010
Last updated: July 27, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Gastrointestinal Symptoms
Dietary Supplement: Bifidobacterium lactis HN019
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
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
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

Further study details as provided by Fonterra Research Centre:

Primary Outcome Measures:
  • Colonic transit time [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gastrointestinal symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Low dose probiotic
Bifidobacterium lactis HN019, 1 billion cfu/day
Dietary Supplement: Bifidobacterium lactis HN019
Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days
Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
Placebo, once a day for 14 days

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171014

Sponsors and Collaborators
Fonterra Research Centre
Danisco
Sprim Advanced Life Sciences
Investigators
Principal Investigator: Philip Waller, MD Accurate Clinical Research, Houston, TX
  More Information

No publications provided

Responsible Party: Pramod Gopal,PhD, Fonterra Research Centre
ClinicalTrials.gov Identifier: NCT01171014     History of Changes
Other Study ID Numbers: #08‐SPUS‐o6‐FON‐01
Study First Received: July 26, 2010
Last Updated: July 27, 2010
Health Authority: New Zealand: Food Safety Authority

ClinicalTrials.gov processed this record on September 18, 2014