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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
History of Changes

July 26, 2010
July 27, 2010
June 2009
December 2009   (final data collection date for primary outcome measure)
Colonic transit time [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01171014 on ClinicalTrials.gov Archive Site
Gastrointestinal symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Bifidobacterium Lactis HN019 on Colonic Transit Time and Digestive Symptoms
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Gastrointestinal Symptoms
  • 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
  • Dietary Supplement: Placebo
    Placebo, once a day for 14 days
  • Experimental: High dose probiotic
    Bifidobacterium lactis HN019, 10 billion cfu/day
    Intervention: Dietary Supplement: Bifidobacterium lactis HN019
  • Experimental: Low dose probiotic
    Bifidobacterium lactis HN019, 1 billion cfu/day
    Intervention: Dietary Supplement: Bifidobacterium lactis HN019
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
25 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01171014
#08‐SPUS‐o6‐FON‐01
No
Pramod Gopal，PhD, Fonterra Research Centre
Fonterra Research Centre
  • Danisco
  • Sprim Advanced Life Sciences
Principal Investigator: Philip Waller, MD Accurate Clinical Research, Houston, TX
Fonterra Research Centre
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP