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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127828
• Other study ID #: U-05-008
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: May 21, 2010
• Start date: September 2005
• Est. completion date: May 2006

Study information

• Verified date: May 2010
• Source: Good Food Practice, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Quality of Life
• Relief of Irritable Bowel Syndrome Symptoms
• Syndrome

Intervention

Other:
• Arla Yoghurt with no probiotic
two servings of 200 ml of investigational products per day
• Probiotic yoghurt (Cultura)
200 ml per day

Locations

Country	Name	City	State
Sweden	Department of Internal Medicine, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Good Food Practice, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of IBS symptoms	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	6 weeks intervention and 6 weeks follow up	Yes
Secondary	Effects on gastrointestinal and extraintestinal symptoms	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.	September 2005 to May 2006	Yes