Alpha-galactosidase Enzyme and Irritable Bowel Syndrome (ALFA)

Verman Oy

Status: Unknown

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: Alpha-galactosidase

Study type: Interventional

Funder types: Industry

Identifiers

NCT01243853

VER001

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

150 participants in 2 patient groups, including a placebo group

Alpha-galactosidase

Active Comparator group

Treatment:

Dietary Supplement: Alpha-galactosidase

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Alpha-galactosidase