Effect of Bifidobacterium Lactis HN019 on Colonic Transit... | NCT01171014

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

NCT01171014

Sponsor

Fonterra Research Centre

Status

Completed

Last Update Posted

Jul 28, 2010Estimated

Enrollment

100Actual

Phase

Phase 2Phase 3

Conditions

Gastrointestinal Symptoms

Interventions

Bifidobacterium lactis HN019
Bifidobacterium lactis HN019
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jul 26, 2010

First Submission Date that Met QC Criteria

Jul 27, 2010

First Posted Date

Jul 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2010

Last Update Posted Date

Jul 28, 2010Estimated

Name	Class
Danisco	INDUSTRY
Sprim Advanced Life Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bifidobacterium lactis HN019	Dietary Supplement	Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days	High dose probiotic

Measure	Description	Time Frame
Colonic transit time		14 days

Measure	Description	Time Frame
Gastrointestinal symptoms		14 days

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip Waller, MD	Accurate Clinical Research, Houston, TX	Principal Investigator

Locations

Not provided