Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption
|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:||Efficacy of Fructose Metabolizing Enzymatic Product Fructosin(R) in Patients With Fructose Malabsorption|
- area under the curve (AUC) of the exhaled breath hydrogen in ppm*min [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
single arm of study in cross-over design
Dietary Supplement: Fructosin
Three capsules of Fructosin before one of the hydrogen breath tests.
Other Name: Frutosin(R)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916487
|Medical University of Graz|
|Graz, Styria, Austria, A-8036|
|Principal Investigator:||Peter Komericki, MD||Medical University of Graz|
|Study Director:||Christian Pongracz, MS||Sciotec Diagnostic Technologies GmbH|