Alpha-galactosidase Enzyme and Irritable Bowel Syndrome
Not Applicable
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Dietary Supplement: Alpha-galactosidase
- Registration Number
- NCT01243853
- Lead Sponsor
- Verman Oy Ab
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alpha-galactosidase Alpha-galactosidase - Placebo Alpha-galactosidase -
- Primary Outcome Measures
Name Time Method IBS symptom severity follow-up (4 months) The IBS symptom severity score (IBS-SSS) questionnaire is used
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gastrolääkärit Oy
🇫🇮Helsinki, Finland
Gastrolääkärit Oy🇫🇮Helsinki, FinlandJari Koskenpato, MD, PhDPrincipal Investigator