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Completed

NCT Number: NCT01171014

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

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

Completed

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Key information

Conditions

Gastrointestinal Symptoms

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifidobacterium lactis HN019

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo, once a day for 14 days

Primary outcomes

  1. Colonic transit time

    Time frame: 14 days

Secondary outcomes

  1. Gastrointestinal symptoms

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Fonterra Research Centre

Industry

Collaborators

  • Danisco
  • Sprim Advanced Life Sciences

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 28, 2010
Registry last updated
Jul 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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