Alpha-galactosidase Enzyme and Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— ALFA  

Official title:

Alpha-galactosidase Enzyme and Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01243853
• Other study ID #: VER001
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2010
• Last updated: January 14, 2011
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: January 2011
• Source: Verman Oy Ab
• Contact: Jari Koskenpato, MD, PhD
• Phone: +358505702835
• Email: jari.koskenpato[@]hus.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in alleviating the symptoms of irritable bowel syndrome (IBS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Alpha-galactosidase
3 months intervention, daily 3 x 3 capsules alpha-galactosidase enzyme (400 GalU/capsule) or 3 x 3 capsules placebo

Locations

Country	Name	City	State
Finland	Gastrolääkärit Oy	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Verman Oy Ab

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IBS symptom severity	The IBS symptom severity score (IBS-SSS) questionnaire is used	baseline	No
Primary	IBS symptom severity	The IBS symptom severity score (IBS-SSS) questionnaire is used	1 month	No
Primary	IBS symptom severity	The IBS symptom severity score (IBS-SSS) questionnaire is used	2 months	No
Primary	IBS symptom severity	The IBS symptom severity score (IBS-SSS) questionnaire is used	3 months	No
Primary	IBS symptom severity	The IBS symptom severity score (IBS-SSS) questionnaire is used	follow-up (4 months)	No