Alpha-galactosidase Enzyme and Irritable Bowel Syndrome

Not Applicable

• Conditions: Irritable Bowel Syndrome

• 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

Study Timeline

• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Study Start: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-14
• Last Update Posted: 2011-01-17
• Primary Completion: 2011-12
• Study Completion: 2012-02

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

Primary Outcome Measures

Name	Time	Method
IBS symptom severity	follow-up (4 months)	The IBS symptom severity score (IBS-SSS) questionnaire is used

Trial Locations

Locations (1)

Gastrolääkärit Oy; 🇫🇮 Helsinki, Finland