Effects of Cultura Yoghurt in Irritable Bowel Syndrome (IBS) Patients on Intestinal and Immunological Changes

This study has been completed.
Sponsor:
Information provided by:
Good Food Practice, Sweden
ClinicalTrials.gov Identifier:
NCT01127828
First received: May 20, 2010
Last updated: May 21, 2010
Last verified: May 2010
  Purpose

To determine the effect of cultura probiotic yoghurt on number of responders to treatment during 8 weeks of treatment in comparison to placebo. To determine the effect of cultura yoghurt on change in total score of (IBS) irritable bowel syndrome severity index during 8 weeks of treatment in comparison to placebo in IBS out patients.


Condition Intervention
Irritable Bowel Syndrome
Relief of Irritable Bowel Syndrome Symptoms
Quality of Life
Other: Arla Yoghurt with no probiotic
Other: Probiotic yoghurt (Cultura)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Cultura Yoghurt on Symptoms Intestinal Flora and Immunological Changes in Patients With Irritable Bowel Syndrome(IBS)

Further study details as provided by Good Food Practice, Sweden:

Primary Outcome Measures:
  • Relief of IBS symptoms [ Time Frame: 6 weeks intervention and 6 weeks follow up ] [ Designated as safety issue: Yes ]
    The primary endpoint of this study was the proportions of patients reporting adequate relief of their IBS symptoms at least 50 % of the weeks during the treatment period


Secondary Outcome Measures:
  • Effects on gastrointestinal and extraintestinal symptoms [ Time Frame: September 2005 to May 2006 ] [ Designated as safety issue: Yes ]
    effects of the investigational products on GI and extraintestinal symptoms assessed with the weekly IBS SSI questionnaire and the scores from the daily questions of the GI symptom questionnaire as weel as the effect on psychological symptoms and quality of life.


Enrollment: 80
Study Start Date: September 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotic yoghurt (Cultura)
Cultura yoghurt containing: L bulgaricus, S thermophilus
Other: Probiotic yoghurt (Cultura)
200 ml per day
Placebo Comparator: Yoghurt with no probiotic Other: Arla Yoghurt with no probiotic
two servings of 200 ml of investigational products per day
Other Name: Arla yoghurt with no probiotic

Detailed Description:

Recent research has shown taht probiotic may give positive effect on symptoms among patients with (IBS) Irritable Bowel Syndrome. The mechanism behind the positive effect are not known but a positive effect on different cytokines are a possible mechanism. Also effect on the large intestine bacterial mass could be of importance.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Signed consent to participate age 18-70 years IBS according to Rome II criteria

-

Exclusion Criteria:

  1. Participation in a clinical study one month prior to screening visit and throughout the study.
  2. Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator.
  3. Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the investigator.
  4. Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
  5. Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the investigator.
  6. Severe psychiatric disease as judged by the investigator.
  7. Previous history of drug or alcohol abuse six months prior to screening.
  8. Intolerance or allergy against milk products or gluten.
  9. Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study.
  10. Consumption of antibiotic drugs 1 month prior to screening and throughout the study.
  11. Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study.
  12. Pregnant or lactating or wish to become pregnant during the period of the study.
  13. Lack of suitability for participation in the study for any reason as judged by the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127828

Locations
Sweden
Department of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Good Food Practice, Sweden
Investigators
Principal Investigator: Magnus Simrén, Ass Prof Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden
Principal Investigator: Magnus Simren, Ass prof. Sahlgrenska hospital, Gothenburg, Sweden
Principal Investigator: Magnus Simrén, Ass proff Medicine, Sahlgrenska University Hospital, S 413 45 Gothenburg, Sweden
  More Information

No publications provided

Responsible Party: Magnus Simrén, Sahlgrenska University Hospital
ClinicalTrials.gov Identifier: NCT01127828     History of Changes
Other Study ID Numbers: U-05-008
Study First Received: May 20, 2010
Last Updated: May 21, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Good Food Practice, Sweden:
IBS (Irritable Bowel Syndrome)
Probiotic yoghurt
Symptom severity

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014