NCT01728610

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
391

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

2.1 years

First QC Date

October 5, 2012

Last Update Submit

January 25, 2016

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndromeprobioticpainbloatingdiarrhoeaconstipation

Outcome Measures

Primary Outcomes (1)

  • Change in functional bowel symptoms

    Validated questionnaire

    0 weeks, 4 weeks, 12 weeks

Secondary Outcomes (5)

  • Change in quality of life

    0 weeks, 4 weeks, 12 weeks

  • Change in anxiety and depression

    0 weeks, 4 weeks and 12 weeks

  • Adequate relief

    Weekly over 3 month intervention

  • Change in faecal microbiota

    0 weeks, 4 weeks, 12 weeks

  • Safety of investigational product

    Throughout the intervention phase

Study Arms (3)

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

Probiotic (Active high)DIETARY_SUPPLEMENT

Higher dose of probiotic supplement

Also known as: Lactobacillus
Active high
Probiotic (Active low)DIETARY_SUPPLEMENT

Lower dose of probiotic supplement

Also known as: Lactobacillus
Active low
PlaceboDIETARY_SUPPLEMENT

Placebo

Also known as: Maltodextrin as placebo
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mehiläinen Töölö

Helsinki, Helsinki, 00260, Finland

Location

Mehiläinen Turku

Turku, Turku, 20100, Finland

Location

MeSH Terms

Conditions

Irritable Bowel SyndromePainDiarrheaConstipation

Interventions

ProbioticsLacteolmaltodextrin

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • 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

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2012

First Posted

November 20, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 26, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(2)