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

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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Alpha-Galactosidase

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41139
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enzyme; Capsules with alpha-galactosidase (enzyme) (400 GaIU x 3) are ingested at breakfast, lunch and dinner.	Dietary supplement: Alpha-Galactosidase; 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).; Other Names: Nogasin
Placebo Comparator: Placebo; 3 capsules with a non-active substance are ingested at breakfast, lunch and dinner	Dietary supplement: Alpha-Galactosidase; 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).; Other Names: Nogasin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): December 1, 2011

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Bloating; Gastrointestinal Symptoms; Distention
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: Nogasin