Status:
UNKNOWN
Alpha-galactosidase Enzyme and Irritable Bowel Syndrome
Lead Sponsor:
Verman Oy Ab
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in alleviating the symptoms of irritable bowel syndrome (IBS).
Eligibility Criteria
Inclusion
- Clinical diagnosis of IBS according to Rome III criteria, additionally abdominal distension or flatulence the most disturbing symptom
- Age 18-65 years
- Colonoscopy conducted within the previous 5 years, finding macroscopically and histologically normal
Exclusion
- Organic GI disease. Treated (min. 1 year) coeliac disease patients, and subjects with known and treated lactose intolerance are allowed to participate
- Malignancy
- Significant gastrointestinal surgery
- Clinically significant aberrancies in the screening-phase laboratory analyses
- Changes in regular medication during the previous 4 weeks
- Pregnancy or breast feeding
- Other disease or state that based on the investigator's evaluation complicates the conduction of the intervention, i.e. alcoholism, dementia
- Hereditary galactosemia
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01243853
Start Date
December 1 2010
End Date
February 1 2012
Last Update
January 17 2011
Active Locations (1)
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1
Gastrolääkärit Oy
Helsinki, Finland, 00100