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Assessment of the Symbiotic Fermented Milk in Patients With Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LCA symbiotic fermented milk
heat-treated fermented milk
Sponsored by
Clinres Farmacija d.o.o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed constipation-predominant irritable bowel syndrome (on the basis of Rome III criteria) (≥ 25 % lumpy or hard stools and ≤ 25 % mushy or watery stools).
  • Meeting Rome III criteria for the determination of irritable bowel syndrome in the last 6 months prior to inclusion and the presence of symptoms such as abdominal pain, bloating and general digestive discomfort at least twice a week in the last 3 months prior to inclusion.
  • Colonoscopy in the last 7 years prior to inclusion with normal results.

Exclusion Criteria:

  • Diarrhoea-predominant irritable bowel syndrome (≥ 25 % mushy or watery stools and ≤ 25 % lumpy or hard stools).
  • Clinical signs of alarm, such as rectorrhagia, fever, recent unexplained weight loss.
  • Organic gastrointestinal diseases, including chronic inflammatory bowel disease and systemic diseases with gastrointestinal difficulties.
  • Severe abdominal pain and the taking of analgesics or antispasmodics for the previous 5 days or more.
  • Having begun treatment with psychotropic medicines or other drugs for the treatment of irritable bowel syndrome within the previous month.
  • Dietary habits that could influence the assessment of the investigational product, such as slimming or a vegetarian diet.
  • Known allergy to ingredient(s) in the investigational product.
  • Known medical or psycho-physical condition that is, in the opinion of the investigator, in conflict with consumption of the investigational product and/or the course of the study.
  • Participation in another clinical study less than one month before inclusion or concurrent participation in another clinical study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Symbiotic

    Placebo

    Arm Description

    LCA symbiotic fermented milk, 180 g pot, twice daily.

    heat-treated fermented milk, 180 g pot, twice daily.

    Outcomes

    Primary Outcome Measures

    Quality of life
    assessed by IBS-QoL questionnaire

    Secondary Outcome Measures

    Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)
    assessed by IBS - Severity Scoring System
    Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)
    assessed by IBS - Severity Scoring System
    Quality of life
    assessed by IBS-QoL questionnaire

    Full Information

    First Posted
    March 12, 2015
    Last Updated
    July 27, 2015
    Sponsor
    Clinres Farmacija d.o.o.
    Collaborators
    Competence Centre for Biotechnology Research and Innovation, European Regional Development Fund, Ministry of Education, Science and Sport of the Republic of Slovenia, Institute of Dairy Science and probiotics, Biotechnical Faculty, UL, Dairy Celeia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02391220
    Brief Title
    Assessment of the Symbiotic Fermented Milk in Patients With Irritable Bowel Syndrome
    Official Title
    The Effect of a Symbiotic LCA Yoghurt on Health-related Quality of Life and the Symptoms of Irritable Bowel Syndrome in Adults: A Randomized, Double-blind, Placebo Controlled, Multicentre Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Clinres Farmacija d.o.o.
    Collaborators
    Competence Centre for Biotechnology Research and Innovation, European Regional Development Fund, Ministry of Education, Science and Sport of the Republic of Slovenia, Institute of Dairy Science and probiotics, Biotechnical Faculty, UL, Dairy Celeia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the effect of a symbiotic fermented milk on health-related quality of life and irritable bowel syndrome (IBS) symptoms in patients with constipation-predominant IBS.
    Detailed Description
    Irritable bowel syndrome (IBS) is one of the most common digestive disorders in the developed world which. It is associated to numerous symptoms, of which the most characteristic are recurrent pain or discomfort in the abdominal region, changes and difficulties related to bowel movements, and bloating. Although not dangerous, the disease may significantly impair the patients' quality of life. Treatment is symptomatic, but currently not very efficient. The use of probiotics in the treatment of IBS is a promising approach and has been the subject of much research in the last two decades. The purpose of this randomized, placebo-controlled study is to assess changes in health-related quality of life in patients with constipation-predominant IBS after regular consumption of symbiotic fermented milk (containing probiotics and dietary fibres) and to assess its effects on some symptoms, like abdominal pain or discomfort, bloating, and chronic constipation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Symbiotic
    Arm Type
    Active Comparator
    Arm Description
    LCA symbiotic fermented milk, 180 g pot, twice daily.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    heat-treated fermented milk, 180 g pot, twice daily.
    Intervention Type
    Other
    Intervention Name(s)
    LCA symbiotic fermented milk
    Intervention Description
    LCA symbiotic fermented milk with the probiotic cultures Lactobacillus acidophilus La-5® and Bifidobacterium animalis ssp. lactis BB-12® and the Beneo dietary fibers.
    Intervention Type
    Other
    Intervention Name(s)
    heat-treated fermented milk
    Intervention Description
    heat-treated fermented milk without probiotic cultures and dietary fibres
    Primary Outcome Measure Information:
    Title
    Quality of life
    Description
    assessed by IBS-QoL questionnaire
    Time Frame
    4 weeks of product consumption
    Secondary Outcome Measure Information:
    Title
    Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)
    Description
    assessed by IBS - Severity Scoring System
    Time Frame
    4 weeks of product consumption
    Title
    Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)
    Description
    assessed by IBS - Severity Scoring System
    Time Frame
    2 weeks of product consumption
    Title
    Quality of life
    Description
    assessed by IBS-QoL questionnaire
    Time Frame
    2 weeks of product consumption

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Confirmed constipation-predominant irritable bowel syndrome (on the basis of Rome III criteria) (≥ 25 % lumpy or hard stools and ≤ 25 % mushy or watery stools). Meeting Rome III criteria for the determination of irritable bowel syndrome in the last 6 months prior to inclusion and the presence of symptoms such as abdominal pain, bloating and general digestive discomfort at least twice a week in the last 3 months prior to inclusion. Colonoscopy in the last 7 years prior to inclusion with normal results. Exclusion Criteria: Diarrhoea-predominant irritable bowel syndrome (≥ 25 % mushy or watery stools and ≤ 25 % lumpy or hard stools). Clinical signs of alarm, such as rectorrhagia, fever, recent unexplained weight loss. Organic gastrointestinal diseases, including chronic inflammatory bowel disease and systemic diseases with gastrointestinal difficulties. Severe abdominal pain and the taking of analgesics or antispasmodics for the previous 5 days or more. Having begun treatment with psychotropic medicines or other drugs for the treatment of irritable bowel syndrome within the previous month. Dietary habits that could influence the assessment of the investigational product, such as slimming or a vegetarian diet. Known allergy to ingredient(s) in the investigational product. Known medical or psycho-physical condition that is, in the opinion of the investigator, in conflict with consumption of the investigational product and/or the course of the study. Participation in another clinical study less than one month before inclusion or concurrent participation in another clinical study.

    12. IPD Sharing Statement

    Learn more about this trial

    Assessment of the Symbiotic Fermented Milk in Patients With Irritable Bowel Syndrome

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