Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption
Primary Purpose
Fructose Malabsorption
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Fructosin
Sponsored by
About this trial
This is an interventional treatment trial for Fructose Malabsorption
Eligibility Criteria
Inclusion Criteria:
- diagnosed fructose malabsorption
Exclusion Criteria:
- Gravidity
- diabetes mellitus
- recent gastrointestinal surgery
- recent endoscopy
- recent antibiotics therapy
Sites / Locations
- Medical University of Graz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm1
Arm Description
single arm of study in cross-over design
Outcomes
Primary Outcome Measures
area under the curve (AUC) of the exhaled breath hydrogen in ppm*min
Secondary Outcome Measures
Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation)
Full Information
NCT ID
NCT00916487
First Posted
June 5, 2009
Last Updated
December 17, 2010
Sponsor
Sciotec Diagnostic Technologies GmbH
Collaborators
Austrian Research Promotion Agency
1. Study Identification
Unique Protocol Identification Number
NCT00916487
Brief Title
Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption
Official Title
Efficacy of Fructose Metabolizing Enzymatic Product Fructosin(R) in Patients With Fructose Malabsorption
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sciotec Diagnostic Technologies GmbH
Collaborators
Austrian Research Promotion Agency
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fructose Malabsorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm1
Arm Type
Experimental
Arm Description
single arm of study in cross-over design
Intervention Type
Dietary Supplement
Intervention Name(s)
Fructosin
Other Intervention Name(s)
Frutosin(R)
Intervention Description
Three capsules of Fructosin before one of the hydrogen breath tests.
Primary Outcome Measure Information:
Title
area under the curve (AUC) of the exhaled breath hydrogen in ppm*min
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation)
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed fructose malabsorption
Exclusion Criteria:
Gravidity
diabetes mellitus
recent gastrointestinal surgery
recent endoscopy
recent antibiotics therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Komericki, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Pongracz, MS
Organizational Affiliation
Sciotec Diagnostic Technologies GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
A-8036
Country
Austria
12. IPD Sharing Statement
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Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption
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