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

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Relief of Irritable Bowel Syndrome Symptoms; Quality of Life
• Interventions: Other: Arla Yoghurt with no probiotic; Other: Probiotic yoghurt (Cultura)

• Registration Number: NCT01127828
• Lead Sponsor: Good Food Practice, Sweden

Brief 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.

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.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2010-05
• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-20
• Study First Posted: 2010-05-21
• Last Update Submitted: 2010-05-21
• Last Update Posted: 2010-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoghurt with no probiotic	Arla Yoghurt with no probiotic	-
Probiotic yoghurt (Cultura)	Probiotic yoghurt (Cultura)	Cultura yoghurt containing: L bulgaricus, S thermophilus

Primary Outcome Measures

Name	Time	Method
Relief of IBS symptoms	6 weeks intervention and 6 weeks follow up	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

Name	Time	Method
Effects on gastrointestinal and extraintestinal symptoms	September 2005 to May 2006	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.

Trial Locations

Locations (1)

Department of Internal Medicine, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden