An interventional study of Fructosin in Fructose Malabsorption, sponsored by Sciotec Diagnostic Technologies GmbH. Completed at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-12-20.
Sponsored by Sciotec Diagnostic Technologies GmbH · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
single arm of study in cross-over design
Dietary Supplement: Fructosin
Three capsules of Fructosin before one of the hydrogen breath tests.
Also known as: Frutosin(R)
area under the curve (AUC) of the exhaled breath hydrogen in ppm*min
Time frame: 4 hours
Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation)
Time frame: 24 hours
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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Sciotec Diagnostic Technologies GmbH