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Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

This study is currently recruiting participants.
Verified November 2012 by Danisco
Sponsor:
Information provided by (Responsible Party):
Danisco
ClinicalTrials.gov Identifier:
NCT01728610
First received: October 5, 2012
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Danisco:

Primary Outcome Measures:
  • Change in functional bowel symptoms [ Time Frame: 0 weeks, 4 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Validated questionnaire


Secondary Outcome Measures:
  • Change in quality of life [ Time Frame: 0 weeks, 4 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Validated questionnaire

  • Change in anxiety and depression [ Time Frame: 0 weeks, 4 weeks and 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, 4 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Detection and quantification of microbes from faecal samples

  • Safety of investigational product [ Time Frame: Throughout the intervention phase ] [ Designated as safety issue: Yes ]
    Recording of adverse events and serious adverse events


Estimated Enrollment: 390
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated 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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728610

Contacts
Contact: Anna Lyra, PhD anna.lyra@dupont.com
Contact: Anneli Tarpila, PhD anneli.tarpila@dupont.com

Locations
Finland
Mehiläinen Töölö Recruiting
Helsinki, Finland, 00260
Contact: Liisa Knaapi     +358 40 577 2965     liisa.knaapi@dupont.com    
Contact: Päivi Kuusniemi         paivi.kuusniemi@mehilainen.fi    
Principal Investigator: Lea Veijola, MD, PhD            
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 Chair: Anneli Tarpila, PhD DuPont Nutrition and Health
Study Director: Anna Lyra, PhD DuPont Nutrition and Health
  More Information

No publications provided

Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT01728610     History of Changes
Other Study ID Numbers: IBS-2
Study First Received: October 5, 2012
Last Updated: November 19, 2012
Health Authority: Finland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on June 18, 2013