Effect of Probiotic Supplement in Alleviating Functional... | NCT01728610

Studies
Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

NCT01728610

Sponsor

Danisco

Status

Completed

Last Update Posted

Jan 26, 2016Estimated

Enrollment

391Actual

Phase

Phase 2

Conditions

Irritable Bowel Syndrome

Interventions

Probiotic (Active high)
Probiotic (Active low)
Placebo

Countries

Finland

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

Jan 2016

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

Oct 2012

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Oct 5, 2012

First Submission Date that Met QC Criteria

Nov 19, 2012

First Posted Date

Nov 20, 2012Estimated

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

Jan 25, 2016

Last Update Posted Date

Jan 26, 2016Estimated

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 is to analyse the effect of a probiotic supplement on functional intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).

Detailed Description

The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on functional intestinal symptoms among subjects diagnosed with IBS according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life, anxiety and depression and adequate relief will be assessed as with questionnaires as outcome measures. The intestinal microbiota will be analysed from faecal samples.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

391Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active high	Active Comparator	Probiotic, high dose	Dietary Supplement: Probiotic (Active high)
Active low	Active Comparator	Probiotic, low dose	Dietary Supplement: Probiotic (Active low)
Placebo	Placebo Comparator	Placebo	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic (Active high)	Dietary Supplement	Higher dose of probiotic supplement	Active high

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in functional bowel symptoms	Validated questionnaire	0 weeks, 4 weeks, 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in quality of life	Validated questionnaire	0 weeks, 4 weeks, 12 weeks
Change in anxiety and depression	Validated questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects aged 18 to 65 fulfilling Rome III criteria for IBS will be recruited. Sufficient general health and orientation for participating in the study is required and will be evaluated by the MDs.

Exclusion Criteria:

Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Lea Veijola, MD	Herttoniemi Hospital	Principal Investigator
Arthur Ouwehand, PhD	DuPont Nutrition and Health	Study Chair
Sampo Lahtinen, PhD	DuPont Nutrition and Health	Study Chair
Anna Lyra, PhD	DuPont Nutrition and Health	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mehiläinen Töölö		Helsinki	Helsinki	00260	Finland
Mehiläinen Turku

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome
D010146	Pain
D003967	Diarrhea
D003248	Constipation

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics
C100843	Lacteol
C008315	maltodextrin

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided