Effects of Cultura Yoghurt in Irritable Bowel Syndrome (IBS) Patients on Intestinal and Immunological Changes
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|ClinicalTrials.gov Identifier: NCT01127828|
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : May 24, 2010
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- 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
- 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.
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
Signed consent to participate age 18-70 years IBS according to Rome II criteria
- Participation in a clinical study one month prior to screening visit and throughout the study.
- Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator.
- Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the investigator.
- Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
- Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the investigator.
- Severe psychiatric disease as judged by the investigator.
- Previous history of drug or alcohol abuse six months prior to screening.
- Intolerance or allergy against milk products or gluten.
- Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study.
- Consumption of antibiotic drugs 1 month prior to screening and throughout the study.
- Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study.
- Pregnant or lactating or wish to become pregnant during the period of the study.
- Lack of suitability for participation in the study for any reason as judged by the investigator.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127828
|Department of Internal Medicine, Sahlgrenska University Hospital|
|Gothenburg, Sweden, 41345|
|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|
|Responsible Party:||Magnus Simrén, Sahlgrenska University Hospital|
|Other Study ID Numbers:||
|First Posted:||May 21, 2010 Key Record Dates|
|Last Update Posted:||May 24, 2010|
|Last Verified:||May 2010|
IBS (Irritable Bowel Syndrome)
Irritable Bowel Syndrome
Colonic Diseases, Functional
Digestive System Diseases