The Effects of Added Enzyme α-Galactosidase at a Carbohydrate-rich Meal in Irritable Bowel Syndrome (IBS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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.
- 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 2012 |
| Estimated Primary Completion Date: | March 2012 (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 |
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| Contact: Lena Böhn, RD | +46 31 3428107 | lena.bohn@gu.se |
| Sweden | |
| Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Sweden, 41139 | |
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: | December 1, 2011 |
| 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 Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013