The Effects of Added Enzyme α-Galactosidase at a Carbohydrate-rich Meal in Irritable Bowel Syndrome (IBS)

Sahlgrenska University Hospital

Status and phase: Completed; Early Phase 1

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: Alpha-Galactosidase

Study type: Interventional

Funder types: Other

Identifiers

NCT01483287

Nogasin

Details and patient eligibility

About

IBS (irritable bowel syndrome) is a functional gastrointestinal disorder which is characterized by recurrent pain and/or discomfort, altered stool form, and abdominal distension. It has been established that food items such as beans, peas, lentils, peppers, and onions can increase gas production. What these have in common is that they all contain large amounts of complex carbohydrates. The enzymes in the small intestine are not able to fully digest these large molecules, which in turn are fermented by the colonic microflora. This fermentation is conducted through the production of short chain fatty acids and gases such as hydrogen and methane. Alpha-Galactosidase is an enzyme that has the ability to break down these indigestible carbohydrates to galactose and sucrose in the small intestine and to facilitate the absorption and minimize the gas production from bacteria in the colon.

The aim of this study is to assess if the gastrointestinal symptoms, above all problems from gas and distension, is alleviated when the enzyme α-Galactosidase (present in Nogasin capsules) is ingested with food.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with Irritable Bowel Syndrome(IBS), (in accordance with ROME III criteria), and
• With the specific symptoms of bloating and/or abdominal distension.

Exclusion criteria

• The patients should not have any other gastrointestinal diseases such as IBD or celiac disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Enzyme

Active Comparator group

Description:

Capsules with alpha-galactosidase (enzyme) (400 GaIU x 3) are ingested at breakfast, lunch and dinner.

Treatment:

Dietary Supplement: Alpha-Galactosidase

Placebo

Placebo Comparator group

Description:

3 capsules with a non-active substance are ingested at breakfast, lunch and dinner

Treatment:

Dietary Supplement: Alpha-Galactosidase