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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT2008-005861-80 |
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| Name | Class |
|---|---|
| Austrian Research Promotion Agency | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 | Experimental | single arm of study in cross-over design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fructosin | Dietary Supplement | Three capsules of Fructosin before one of the hydrogen breath tests. |
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| Measure | Description | Time Frame |
|---|---|---|
| area under the curve (AUC) of the exhaled breath hydrogen in ppm*min | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation) | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Komericki, MD | Medical University of Graz | Principal Investigator |
| Christian Pongracz, MS | Sciotec Diagnostic Technologies GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Styria | A-8036 | Austria |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 20, 2012 | |
| Reset | Dec 18, 2012 | |
| Release | Jan 8, 2013 | |
| Reset | Feb 11, 2013 | |
| Release | Feb 12, 2013 | |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 20, 2012 | Dec 18, 2012 | |||
| Jan 8, 2013 |
| ID | Term |
|---|---|
| D005633 | Fructose Intolerance |
| ID | Term |
|---|---|
| D015318 | Fructose Metabolism, Inborn Errors |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
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| Feb 11, 2013 |
| Feb 12, 2013 | Yes |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |