CClinicalTrials.gg
CompletedNCT01171014Updated Jul 28, 2010

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

A Phase 2/3 interventional study of Bifidobacterium lactis HN019 and Bifidobacterium lactis HN019 in Gastrointestinal Symptoms, sponsored by Fonterra Research Centre. Completed. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-07-28.

Sponsored by Fonterra Research Centre · Phase 2/3, Interventional, and Supportive care

Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastrointestinal Symptoms
03

In context

Lead sponsor

Fonterra Research Centre is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    High dose probiotic

    Bifidobacterium lactis HN019, 10 billion cfu/day

    Dietary Supplement: Bifidobacterium lactis HN019

  • Experimental
    Low dose probiotic

    Bifidobacterium lactis HN019, 1 billion cfu/day

    Dietary Supplement: Bifidobacterium lactis HN019

  • Placebo comparator
    Placebo

    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementBifidobacterium lactis HN019

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

  • Dietary supplementBifidobacterium lactis HN019

    Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days

  • Dietary supplementPlacebo

    Placebo, once a day for 14 days

06

What researchers measure

Primary outcomes

  1. Colonic transit time

    Time frame: 14 days

Secondary outcomes

  1. Gastrointestinal symptoms

    Time frame: 14 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01171014
Lead sponsor
Fonterra Research Centre
Collaborators
Danisco, Sprim Advanced Life Sciences
First posted
Jul 28, 2010
Start date
Jun 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Jul 28, 2010

Study contacts

Philip Waller, MD
principal investigator · Accurate Clinical Research, Houston, TX

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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