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

Early Phase 1

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Alpha-Galactosidase

• Registration Number: NCT01483287
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-12-01
• Primary Completion: 2013-06
• Study Completion: 2013-08
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Enzyme	Alpha-Galactosidase	Capsules with alpha-galactosidase (enzyme) (400 GaIU x 3) are ingested at breakfast, lunch and dinner.
Placebo	Alpha-Galactosidase	3 capsules with a non-active substance are ingested at breakfast, lunch and dinner

Primary Outcome Measures

Name	Time	Method
Change in symptoms	24 hours	Symptom questionnaire are filled in each half hour during trial (hours 0800-1530),four times between hours 1700-2000, once at bedtime, once at following morning before breakfast. Changes between visit 1 and visit 2 are registered.

Secondary Outcome Measures

Name	Time	Method
Changes in expiration air	24 hours	The expiration air is analyzed each half hour between hours 0800-1530 to examine the content of methane and hydrogen gas. Changes between visit 1 and visit 2 are registered.

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden