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Effect of Probiotic Supplement on Bowel Function (IBS2)

This study has been terminated.
(Protocol violations)
Sponsor:
Information provided by (Responsible Party):
Danisco
ClinicalTrials.gov Identifier:
NCT01475929
First received: September 20, 2011
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Irritable Bowel Syndrome
 Dietary Supplement: Probiotic supplement
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Probiotic Supplement on Bowel Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Danisco:

Primary Outcome Measures:
  • Change in functional bowel symptoms [ Time Frame: 0 weeks, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Validated questionnaire


Secondary Outcome Measures:
  • Change in quality of life [ Time Frame: 0 weeks, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Validated questionnaire

  • Adequate relief [ Time Frame: Weekly over 3 month intervention ] [ Designated as safety issue: No ]
    Weekly question

  • Change in faecal microbiota [ Time Frame: 0 weeks, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Quantification of selected microbes and the intervention strain from faecal samples


Enrollment: 149
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotic low
Lower dose of probiotic supplement
 Dietary Supplement: Probiotic supplement
A single strain probiotic supplement given at two doses
Other Name: Lactobacillus
Placebo Comparator: Placebo Dietary Supplement: Probiotic supplement
A single strain probiotic supplement given at two doses
Other Name: Lactobacillus
Active Comparator: Probiotic high
Higher dose of probiotic supplement
 Dietary Supplement: Probiotic supplement
A single strain probiotic supplement given at two doses
Other Name: Lactobacillus

Detailed Description:

The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on symptoms of irritable bowel syndrome (IBS). Fulfillment of Rome III criteria will be used as inclusion criterion. Subjective assessment of bowel symptoms, IBS-related quality of life and adequate relief will be assessed as outcome measures.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health are exclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475929

Locations
Finland
Herttoniemi Hospital
Helsinki, Finland, 00800
Sponsors and Collaborators
Danisco
Investigators
Study Chair: Arthur Ouwehand, PhD Danisco
Study Director: Anna Lyra, PhD Danisco
Principal Investigator: Lea Veijola, MD Helsinki Health Centre
Study Chair: Sampo Lahtinen, PhD Danisco
Study Director: Anneli Tarpila, PhD Danisco
  More Information

No publications provided

Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT01475929     History of Changes
Other Study ID Numbers: IBS2
Study First Received: September 20, 2011
Last Updated: August 14, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by Danisco:
irritable bowel syndrome
probiotic

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013