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Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01728610
First Posted: November 20, 2012
Last Update Posted: January 26, 2016
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.
Information provided by (Responsible Party):
Danisco
  Purpose
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).

Condition Intervention Phase
Irritable Bowel Syndrome Dietary Supplement: Probiotic (Active high) Dietary Supplement: Probiotic (Active low) Dietary Supplement: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms (IBS-2)

Resource links provided by NLM:


Further study details as provided by Danisco:

Primary Outcome Measures:
  • Change in functional bowel symptoms [ Time Frame: 0 weeks, 4 weeks, 12 weeks ]
    Validated questionnaire


Secondary Outcome Measures:
  • Change in quality of life [ Time Frame: 0 weeks, 4 weeks, 12 weeks ]
    Validated questionnaire

  • Change in anxiety and depression [ Time Frame: 0 weeks, 4 weeks and 12 weeks ]
    Validated questionnaire

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

  • Change in faecal microbiota [ Time Frame: 0 weeks, 4 weeks, 12 weeks ]
    Detection and quantification of microbes from faecal samples

  • Safety of investigational product [ Time Frame: Throughout the intervention phase ]
    Recording of adverse events and serious adverse events


Enrollment: 391
Study Start Date: October 2012
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active high
Probiotic, high dose
Dietary Supplement: Probiotic (Active high)
Higher dose of probiotic supplement
Other Name: Lactobacillus
Active Comparator: Active low
Probiotic, low dose
Dietary Supplement: Probiotic (Active low)
Lower dose of probiotic supplement
Other Name: Lactobacillus
Placebo Comparator: Placebo
Placebo
Dietary Supplement: Placebo
Placebo
Other Name: Maltodextrin as placebo

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.
  Eligibility

Information from the National Library of Medicine

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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 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.
  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): NCT01728610


Locations
Finland
Mehiläinen Töölö
Helsinki, Finland, 00260
Mehiläinen Turku
Turku, Finland, 20100
Sponsors and Collaborators
Danisco
Investigators
Principal Investigator: Lea Veijola, MD Herttoniemi Hospital
Study Chair: Arthur Ouwehand, PhD DuPont Nutrition and Health
Study Chair: Sampo Lahtinen, PhD DuPont Nutrition and Health
Study Director: Anna Lyra, PhD DuPont Nutrition and Health
  More Information

Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT01728610     History of Changes
Other Study ID Numbers: IBS-2
First Submitted: October 5, 2012
First Posted: November 20, 2012
Last Update Posted: January 26, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Danisco:
irritable bowel syndrome
probiotic
pain
bloating
diarrhoea
constipation

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