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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01483287
First Posted: December 1, 2011
Last Update Posted: November 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Magnus Simrén, Sahlgrenska University Hospital, Sweden
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome Dietary Supplement: Alpha-Galactosidase Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Added Enzyme α-Galactosidase at a Carbohydrate-rich Meal in IBS

Resource links provided by NLM:


Further study details as provided by Magnus Simrén, Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Change in symptoms [ Time Frame: 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:
  • Changes in expiration air [ Time Frame: 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.


Enrollment: 20
Study Start Date: November 2011
Study Completion Date: August 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Nogasin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483287


Locations
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, 41139
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
  More Information

Responsible Party: Magnus Simrén, Clinical Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01483287     History of Changes
Other Study ID Numbers: Nogasin
First Submitted: November 22, 2011
First Posted: December 1, 2011
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Magnus Simrén, Sahlgrenska University Hospital, Sweden:
Gastrointestinal Symptoms
Bloating
Distention

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases