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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01171014

Enrollment

100

Registered

2010-07-28

Start date

2009-06-30

Completion date

2009-12-31

Last updated

2010-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Symptoms

Brief 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.

Interventions

DIETARY_SUPPLEMENTBifidobacterium lactis HN019

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

DIETARY_SUPPLEMENTPlacebo

Placebo, once a day for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

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

* 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

Design outcomes

Primary

Measure	Time frame
Colonic transit time	14 days

Secondary

Measure	Time frame
Gastrointestinal symptoms	14 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026