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

NCT01483287 | Completed Early Phase 1

• 1 other identifier: Nogasin
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

Gastrointestinal Symptoms; Bloating; Distention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in expiration air

  24 hours

Study Arms (2)

Enzyme

ACTIVE COMPARATOR

Capsules with alpha-galactosidase (enzyme) (400 GaIU x 3) are ingested at breakfast, lunch and dinner.

Dietary Supplement: Alpha-Galactosidase

Placebo

PLACEBO COMPARATOR

3 capsules with a non-active substance are ingested at breakfast, lunch and dinner

Dietary Supplement: Alpha-Galactosidase

Interventions

Alpha-Galactosidase DIETARY_SUPPLEMENT

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).

Also known as: Nogasin

Enzyme; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Irritable Bowel Syndrome(IBS), (in accordance with ROME III criteria), and
• With the specific symptoms of bloating and/or abdominal distension.

You may not qualify if:

• The patients should not have any other gastrointestinal diseases such as IBD or celiac disease.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41139, Sweden

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Dilatation, Pathologic

Interventions

alpha-Galactosidase

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Galactosidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 1, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

SE (1)