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

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Added Enzyme α-Galactosidase at a Carbohydrate-rich Meal in IBS

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Alpha-Galactosidase


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enzyme<br>Capsules with alpha-galactosidase (enzyme) (400 GaIU x 3) are ingested at breakfast, lunch and dinner. | Dietary Supplement: Alpha-Galactosidase<br>* The study is conducted during a total of two days at two different occasions. Visit 1: The patients will be served breakfast and lunch at the gastro unit and dinner will be enclosed when the patient leave for home. At each meal (breakfast, lunch, and dinner) the participants will ingest three capsules with a total content of 1200 GaIU alpha-galactosidase-randomized to be either the enzyme (α-Galactosidase) or a non-active substance (placebo). Visit 2: The procedure from visit 1 will recur after at least two weeks has passed - except that the content of the capsules will be opposite from the first visit. No other food or beverage are ingested from 1800 hours the evening before the intervention day until breakfast the day after intervention (no exact time).<br>* Other names: Nogasin;|
| Placebo Comparator: Placebo<br>3 capsules with a non-active substance are ingested at breakfast, lunch and dinner | Dietary Supplement: Alpha-Galactosidase<br>* The study is conducted during a total of two days at two different occasions. Visit 1: The patients will be served breakfast and lunch at the gastro unit and dinner will be enclosed when the patient leave for home. At each meal (breakfast, lunch, and dinner) the participants will ingest three capsules with a total content of 1200 GaIU alpha-galactosidase-randomized to be either the enzyme (α-Galactosidase) or a non-active substance (placebo). Visit 2: The procedure from visit 1 will recur after at least two weeks has passed - except that the content of the capsules will be opposite from the first visit. No other food or beverage are ingested from 1800 hours the evening before the intervention day until breakfast the day after intervention (no exact time).<br>* Other names: Nogasin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptoms | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in expiration air | 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. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Symptoms, Bloating, Distention