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

• ClinicalTrials.gov Identifier: NCT01127828
• Recruitment Status: Completed
• First Posted: May 21, 2010
• Last Update Posted: May 24, 2010
• Sponsor: Good Food Practice, Sweden
• Information provided by: Good Food Practice, Sweden

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome; Relief of Irritable Bowel Syndrome Symptoms; Quality of Life	Other: Arla Yoghurt with no probiotic; Other: Probiotic yoghurt (Cultura)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Cultura Yoghurt on Symptoms Intestinal Flora and Immunological Changes in Patients With Irritable Bowel Syndrome(IBS)
• Study Start Date: September 2005
• Actual Primary Completion Date: May 2006
• Actual Study Completion Date: May 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Relief of IBS symptoms [ Time Frame: 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 :

1. Effects on gastrointestinal and extraintestinal symptoms [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

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

• Responsible Party: Magnus Simrén, Sahlgrenska University Hospital
• ClinicalTrials.gov Identifier: NCT01127828
• Other Study ID Numbers: U-05-008
• First Posted: May 21, 2010
• Last Update Posted: May 24, 2010
• Last Verified: May 2010

Keywords provided by Good Food Practice, Sweden:

IBS (Irritable Bowel Syndrome); Probiotic yoghurt; Symptom severity

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases