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

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391220
• Other study ID #: KC_BRIN
• Status: Completed
• Phase: N/A
• First received: March 12, 2015
• Last updated: July 27, 2015
• Start date: February 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2015
• Source: Clinres Farmacija d.o.o.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• LCA symbiotic fermented milk
LCA symbiotic fermented milk with the probiotic cultures Lactobacillus acidophilus La-5® and Bifidobacterium animalis ssp. lactis BB-12® and the Beneo dietary fibers.
• heat-treated fermented milk
heat-treated fermented milk without probiotic cultures and dietary fibres

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Clinres Farmacija d.o.o.	Competence Centre for Biotechnology Research and Innovation, Dairy Celeia, European Regional Development Fund, Institute of Dairy Science and probiotics, Biotechnical Faculty, UL, Ministry of Education, Science and Sport of the Republic of Slovenia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	assessed by IBS-QoL questionnaire	4 weeks of product consumption	No
Secondary	Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)	assessed by IBS - Severity Scoring System	4 weeks of product consumption	No
Secondary	Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)	assessed by IBS - Severity Scoring System	2 weeks of product consumption	No
Secondary	Quality of life	assessed by IBS-QoL questionnaire	2 weeks of product consumption	No