Irritable Bowel Syndrome
Conditions
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).
Interventions
DIETARY_SUPPLEMENTAlpha-galactosidase
3 months intervention, daily 3 x 3 capsules alpha-galactosidase enzyme (400 GalU/capsule) or 3 x 3 capsules placebo
Sponsors
Verman Oy Ab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IBS symptom severity | baseline | The IBS symptom severity score (IBS-SSS) questionnaire is used |
Countries
Finland
Contacts
Primary ContactJari Koskenpato, MD, PhD
Outcome results
None listed