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Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

Probiotic (Active high)

Probiotic (Active low)

Placebo

About this trial

This is an interventional supportive care trial for Irritable Bowel Syndrome focused on measuring irritable bowel syndrome, probiotic, pain, bloating, diarrhoea, constipation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mehiläinen Töölö
Mehiläinen Turku

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active high

Active low

Placebo

Arm Description

Probiotic, high dose

Probiotic, low dose

Placebo

Outcomes

Primary Outcome Measures

Change in functional bowel symptoms

Validated questionnaire

Secondary Outcome Measures

Change in quality of life

Validated questionnaire

Change in anxiety and depression

Validated questionnaire

Adequate relief

Weekly question

Change in faecal microbiota

Detection and quantification of microbes from faecal samples

Safety of investigational product

Recording of adverse events and serious adverse events

Full Information

NCT ID

NCT01728610

First Posted

October 5, 2012

Last Updated

January 25, 2016

Sponsor

Danisco

1. Study Identification

Unique Protocol Identification Number

NCT01728610

Brief Title

Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

Official Title

Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms (IBS-2)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Danisco

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome, probiotic, pain, bloating, diarrhoea, constipation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

391 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active high

Arm Type

Active Comparator

Arm Description

Probiotic, high dose

Arm Title

Active low

Arm Type

Active Comparator

Arm Description

Probiotic, low dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic (Active high)

Other Intervention Name(s)

Lactobacillus

Intervention Description

Higher dose of probiotic supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic (Active low)

Other Intervention Name(s)

Lactobacillus

Intervention Description

Lower dose of probiotic supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Other Intervention Name(s)

Maltodextrin as placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change in functional bowel symptoms

Description

Validated questionnaire

Time Frame

0 weeks, 4 weeks, 12 weeks

Secondary Outcome Measure Information:

Title

Change in quality of life

Description

Validated questionnaire

Time Frame

0 weeks, 4 weeks, 12 weeks

Title

Change in anxiety and depression

Description

Validated questionnaire

Time Frame

0 weeks, 4 weeks and 12 weeks

Title

Adequate relief

Description

Weekly question

Time Frame

Weekly over 3 month intervention

Title

Change in faecal microbiota

Description

Detection and quantification of microbes from faecal samples

Time Frame

0 weeks, 4 weeks, 12 weeks

Title

Safety of investigational product

Description

Recording of adverse events and serious adverse events

Time Frame

Throughout the intervention phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lea Veijola, MD

Organizational Affiliation

Herttoniemi Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arthur Ouwehand, PhD

Organizational Affiliation

DuPont Nutrition and Health

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Sampo Lahtinen, PhD

Organizational Affiliation

DuPont Nutrition and Health

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Anna Lyra, PhD

Organizational Affiliation

DuPont Nutrition and Health

Official's Role

Study Director

Facility Information:

Facility Name

Mehiläinen Töölö

City

Helsinki

ZIP/Postal Code

00260

Country

Finland

Facility Name

Mehiläinen Turku

City

Turku

ZIP/Postal Code

20100

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

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