Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fructose Malabsorption |
Dietary Supplement: Fructosin |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 65 |
| Study Start Date: | June 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm1
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)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- diagnosed fructose malabsorption
Exclusion Criteria:
- Gravidity
- diabetes mellitus
- recent gastrointestinal surgery
- recent endoscopy
- recent antibiotics therapy
Contacts and Locations| Austria | |
| 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 |
More Information
No publications provided
| Responsible Party: | Pongracz Christian, Sciotec Diagnostic Technologies GmbH |
| ClinicalTrials.gov Identifier: | NCT00916487 History of Changes |
| Other Study ID Numbers: | Fructo001, EUDRACT2008-005861-80 |
| Study First Received: | June 5, 2009 |
| Last Updated: | December 17, 2010 |
| Health Authority: | Austria: Agency for Health and Food Safety Austria: Ethikkommission |
Additional relevant MeSH terms:
|
Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013