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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Irritable Bowel Syndrome; Relief of Irritable Bowel Syndrome Symptoms
• Intervention / Treatment: Other: Probiotic yoghurt (Cultura); Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Department of Internal Medicine, Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: May 20, 2010
• First Submitted That Met QC Criteria: May 20, 2010
• First Posted (Estimate): May 21, 2010

Study Record Updates

• Last Update Posted (Estimate): May 24, 2010
• Last Update Submitted That Met QC Criteria: May 21, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: IBS (Irritable Bowel Syndrome); Symptom severity; Probiotic yoghurt
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: U-05-008