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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic yoghurt (Cultura) | Active Comparator | Cultura yoghurt containing: L bulgaricus, S thermophilus |
|
| Yoghurt with no probiotic | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arla Yoghurt with no probiotic | Other | two servings of 200 ml of investigational products per day |
|
| 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 |
| 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 |
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Inclusion Criteria:
Signed consent to participate age 18-70 years IBS according to Rome II criteria
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
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| Probiotic yoghurt (Cultura) | Other | 200 ml per day |
|
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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