Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms (IBS-2)

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).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic (Active high); Dietary supplement: Probiotic (Active low)

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.

• Study Type: Interventional
• Enrollment (Actual): 391
• Phase: Phase 2

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00260
    • Mehiläinen Töölö
  • Turku, Finland, 20100
    • Mehiläinen Turku

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo; Other Names: Maltodextrin as placebo
Active Comparator: Active high; Probiotic, high dose	Dietary supplement: Probiotic (Active high); Higher dose of probiotic supplement; Other Names: Lactobacillus
Active Comparator: Active low; Probiotic, low dose	Dietary supplement: Probiotic (Active low); Lower dose of probiotic supplement; Other Names: Lactobacillus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional bowel symptoms	Validated questionnaire	0 weeks, 4 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate relief	Weekly question	Weekly over 3 month intervention
Change in quality of life	Validated questionnaire	0 weeks, 4 weeks, 12 weeks
Change in anxiety and depression	Validated questionnaire	0 weeks, 4 weeks and 12 weeks
Change in faecal microbiota	Detection and quantification of microbes from faecal samples	0 weeks, 4 weeks, 12 weeks
Safety of investigational product	Recording of adverse events and serious adverse events	Throughout the intervention phase

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: October 5, 2012
• First Submitted That Met QC Criteria: November 19, 2012
• First Posted (Estimate): November 20, 2012

Study Record Updates

• Last Update Posted (Estimate): January 26, 2016
• Last Update Submitted That Met QC Criteria: January 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: pain; probiotic; diarrhoea; bloating; constipation; irritable bowel syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: IBS-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO