Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00916487
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : December 20, 2010
Austrian Research Promotion Agency
Information provided by:
Sciotec Diagnostic Technologies GmbH

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.

Condition or disease Intervention/treatment Phase
Fructose Malabsorption Dietary Supplement: Fructosin Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Fructose Metabolizing Enzymatic Product Fructosin(R) in Patients With Fructose Malabsorption
Study Start Date : June 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. area under the curve (AUC) of the exhaled breath hydrogen in ppm*min [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation) [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diagnosed fructose malabsorption

Exclusion Criteria:

  • Gravidity
  • diabetes mellitus
  • recent gastrointestinal surgery
  • recent endoscopy
  • recent antibiotics therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00916487

Medical University of Graz
Graz, Styria, Austria, A-8036
Sponsors and Collaborators
Sciotec Diagnostic Technologies GmbH
Austrian Research Promotion Agency
Principal Investigator: Peter Komericki, MD Medical University of Graz
Study Director: Christian Pongracz, MS Sciotec Diagnostic Technologies GmbH

Responsible Party: Pongracz Christian, Sciotec Diagnostic Technologies GmbH Identifier: NCT00916487     History of Changes
Other Study ID Numbers: Fructo001
First Posted: June 9, 2009    Key Record Dates
Last Update Posted: December 20, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases