Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption

Fructose Malabsorption Clinical Trial

Official title:

Efficacy of Fructose Metabolizing Enzymatic Product Fructosin(R) in Patients With Fructose Malabsorption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916487
• Other study ID #: Fructo001
• Secondary ID: EUDRACT2008-0058
• Status: Completed
• Phase: N/A
• First received: June 5, 2009
• Last updated: December 17, 2010
• Start date: June 2009
• Est. completion date: August 2010

Study information

• Verified date: December 2010
• Source: Sciotec Diagnostic Technologies GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the enzymatic product Frucosin(R) is able to degrade fructose in vivo in the small intestine of patients with known fructose malabsorption by measuring hydrogen in the expiratory air.

Description:

Fructose malabsorption is a digestive disorder in which the uptake of fructose in the small intestine is deficient. This leads to an increase of the concentration of fructose in the large intestine after the intake of fructose-rich meals. The exzess fructose is then degraded by intestinal microbes into CO2, CH4, H2 and short chain fatty acids causing symptoms like bloating, diarrhea, flatulence or stomach pain.

The clinical diagnosis requires a hydrogen breath test after challenge with fructose. After an oral challenge with fructose the emerging hydrogen is measured in the expiratory air. A fructose malabsorption is diagnosed if the hydrogen in the expiratory air reaches 20ppm or more.

In the course of this study the participants will take 2 hydrogen breath tests. Before each of these tests the participants will take either the active treatment (Fructosin(R)) or a placebo. The active treatment should reduce the exhaled hydrogen indicating a reduced concentration of fructose in the large intestine after fructose metabolization by the verum.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosed fructose malabsorption

Exclusion Criteria:

• Gravidity

• diabetes mellitus

• recent gastrointestinal surgery

• recent endoscopy

• recent antibiotics therapy

Related Conditions & MeSH terms

• Fructose Malabsorption
• Malabsorption Syndromes

Intervention

Dietary Supplement:
• Fructosin
Three capsules of Fructosin before one of the hydrogen breath tests.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (2)

Lead Sponsor	Collaborator
Sciotec Diagnostic Technologies GmbH	Austrian Research Promotion Agency

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	area under the curve (AUC) of the exhaled breath hydrogen in ppm*min		4 hours
Secondary	Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation)		24 hours