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
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
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.
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
NCT ID
NCT02391220
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
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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