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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483287
• Other study ID #: Nogasin
• Status: Completed
• Phase: Phase 0
• First received: November 22, 2011
• Last updated: November 17, 2014
• Start date: November 2011
• Est. completion date: August 2013

Study information

• Verified date: November 2014
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

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 (a-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).

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No