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

NCT02391220 | Completed

• 1 other identifier: KC_BRIN
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Quality of life

  assessed by IBS-QoL questionnaire

  4 weeks of product consumption

Secondary Outcomes (3)

• Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)

  4 weeks of product consumption

• Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)

  2 weeks of product consumption

• Quality of life

  2 weeks of product consumption

Study Arms (2)

Symbiotic

ACTIVE COMPARATOR

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

Other: LCA symbiotic fermented milk

Placebo

PLACEBO COMPARATOR

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

Other: heat-treated fermented milk

Interventions

LCA symbiotic fermented milk OTHER

LCA symbiotic fermented milk with the probiotic cultures Lactobacillus acidophilus La-5® and Bifidobacterium animalis ssp. lactis BB-12® and the Beneo dietary fibers.

Symbiotic

heat-treated fermented milk OTHER

heat-treated fermented milk without probiotic cultures and dietary fibres

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed constipation-predominant irritable bowel syndrome (on the basis of Rome III criteria) (≥ 25 % lumpy or hard stools and ≤ 25 % mushy or watery stools).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: February 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 28, 2015

Record last verified: 2015-03