Trial | NCT01243853  Report issue

Official Title

Alpha-galactosidase Enzyme and Irritable Bowel Syndrome

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    150
The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in alleviating the symptoms of irritable bowel syndrome (IBS).
Study Started
Dec 31
2010
Primary Completion
Dec 31
2011
Anticipated
Study Completion
Feb 29
2012
Anticipated
Last Update
Jan 17
2011
Estimate

Dietary Supplement Alpha-galactosidase

3 months intervention, daily 3 x 3 capsules alpha-galactosidase enzyme (400 GalU/capsule) or 3 x 3 capsules placebo

Alpha-galactosidase Active Comparator

Placebo Placebo Comparator

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted