Status:
COMPLETED
Effects of Activia in IBS
Lead Sponsor:
Sahlgrenska University Hospital
Collaborating Sponsors:
Danone Global Research & Innovation Center
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the association between gut microbiota, immunology and typical pathophysiological factors in patients with IBS (all subtypes) AND to assess the effect of Ac...
Detailed Description
BACKGROUND There is a wide variety of symptoms in IBS, irritable bowel syndrome, both among individuals and in the symptoms of a specific individual. Pathophysiological factors that are of importance...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Age: between 18 and 65 years old at baseline visit
- IBS according to the Rome III criteria
- Ability to understand and willingness to comply to the study procedures
Exclusion
- Participation in another clinical study 1 month prior to screening visit and throughout the study
- Abnormal results on the screening laboratory tests clinically relevant for study participation
- Other gastrointestinal disease(s) explaining the patient's symptoms, as judged by the investigator
- Other severe disease(s) such as malignancy, severe heart disease, kidney disease or neurological disease
- Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, weight loss or fever
- Severe psychiatric disease
- Previous history of drug or alcohol abuse 6 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 antibiotics 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01252550
Start Date
May 1 2010
End Date
August 1 2014
Last Update
November 18 2014
Active Locations (3)
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1
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 41345
2
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
3
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, Sweden, S413-45