Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption

Not Applicable

Completed

• Conditions: Fructose Malabsorption
• Interventions: Dietary Supplement: Fructosin

• Registration Number: NCT00916487
• Lead Sponsor: Sciotec Diagnostic Technologies GmbH

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-09
• Primary Completion: 2010-05
• Study Completion: 2010-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-17
• Last Update Posted: 2010-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• diagnosed fructose malabsorption

Exclusion Criteria

• Gravidity
• diabetes mellitus
• recent gastrointestinal surgery
• recent endoscopy
• recent antibiotics therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm1	Fructosin	single arm of study in cross-over design

Primary Outcome Measures

Name	Time	Method
area under the curve (AUC) of the exhaled breath hydrogen in ppm*min	4 hours

Secondary Outcome Measures

Name	Time	Method
Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation)	24 hours

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria