NCT01475929

Brief Summary

The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
149

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

September 20, 2011

Last Update Submit

August 11, 2015

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndromeprobiotic

Outcome Measures

Primary Outcomes (1)

  • Change in functional bowel symptoms

    Validated questionnaire

    0 weeks, 6 weeks, 12 weeks

Secondary Outcomes (3)

  • Change in quality of life

    0 weeks, 6 weeks, 12 weeks

  • Adequate relief

    Weekly over 3 month intervention

  • Change in faecal microbiota

    0 weeks, 6 weeks, 12 weeks

Study Arms (3)

Probiotic low

ACTIVE COMPARATOR

Lower dose of probiotic supplement

Dietary Supplement: Probiotic supplement

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Probiotic supplement

Probiotic high

ACTIVE COMPARATOR

Higher dose of probiotic supplement

Dietary Supplement: Probiotic supplement

Interventions

Probiotic supplementDIETARY_SUPPLEMENT

A single strain probiotic supplement given at two doses

Also known as: Lactobacillus
PlaceboProbiotic highProbiotic low

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 with functional bowel symptoms and 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herttoniemi Hospital

Helsinki, Helsinki, 00800, Finland

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Arthur Ouwehand, PhD

    Danisco

    STUDY CHAIR

  • Anna Lyra, PhD

    Danisco

    STUDY DIRECTOR

  • Lea Veijola, MD

    Helsinki Health Centre

    PRINCIPAL INVESTIGATOR

  • Sampo Lahtinen, PhD

    Danisco

    STUDY CHAIR

  • Anneli Tarpila, PhD

    Danisco

    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

September 20, 2011

First Posted

November 22, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

FI(1)