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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Sahlgrenska University Hospital, Sweden
Sponsor:
Information provided by (Responsible Party):
Magnus Simrén, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01483287
First received: November 22, 2011
Last updated: May 28, 2013
Last verified: May 2013
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Change in symptoms [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: August 2013
Estimated 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483287

Contacts
Contact: Lena Böhn, RD +46 31 3428107 lena.bohn@gu.se

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

No publications provided

Responsible Party: Magnus Simrén, Clinical Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01483287     History of Changes
Other Study ID Numbers: Nogasin
Study First Received: November 22, 2011
Last Updated: May 28, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014