We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Probiotic Supplement on Bowel Function (IBS2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01475929
Recruitment Status : Terminated (Protocol violations)
First Posted : November 22, 2011
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Probiotic supplement Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Probiotic Supplement on Bowel Function
Study Start Date : June 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change in functional bowel symptoms [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Validated questionnaire


Secondary Outcome Measures :
  1. Change in quality of life [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Validated questionnaire

  2. Adequate relief [ Time Frame: Weekly over 3 month intervention ]
    Weekly question

  3. Change in faecal microbiota [ Time Frame: 0 weeks, 6 weeks, 12 weeks ]
    Quantification of selected microbes and the intervention strain from faecal samples


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT01475929     History of Changes
Other Study ID Numbers: IBS2
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

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