NCT01171014

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
Last Updated

July 28, 2010

Status Verified

July 1, 2010

Enrollment Period

6 months

First QC Date

July 26, 2010

Last Update Submit

July 27, 2010

Conditions

Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (1)

  • Colonic transit time

    14 days

Secondary Outcomes (1)

  • Gastrointestinal symptoms

    14 days

Study Arms (3)

High dose probiotic

EXPERIMENTAL

Bifidobacterium lactis HN019, 10 billion cfu/day

Dietary Supplement: Bifidobacterium lactis HN019

Low dose probiotic

EXPERIMENTAL

Bifidobacterium lactis HN019, 1 billion cfu/day

Dietary Supplement: Bifidobacterium lactis HN019

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Bifidobacterium lactis HN019DIETARY_SUPPLEMENT

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

High dose probiotic
PlaceboDIETARY_SUPPLEMENT

Placebo, once a day for 14 days

Placebo

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy males and females aged 25 to 65 years
  • stool type 2-4 on the Bristol Stool Chart
  • to 3 bowel movements per week

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Philip Waller, MD

    Accurate Clinical Research, Houston, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 26, 2010

First Posted

July 28, 2010

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 28, 2010

Record last verified: 2010-07