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Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption

This study has been completed.
Austrian Research Promotion Agency
Information provided by:
Sciotec Diagnostic Technologies GmbH Identifier:
First received: June 5, 2009
Last updated: December 17, 2010
Last verified: December 2010
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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Fructose Metabolizing Enzymatic Product Fructosin(R) in Patients With Fructose Malabsorption

Resource links provided by NLM:

Further study details as provided by Sciotec Diagnostic Technologies GmbH:

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

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

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Pongracz Christian, Sciotec Diagnostic Technologies GmbH Identifier: NCT00916487     History of Changes
Other Study ID Numbers: Fructo001
Study First Received: June 5, 2009
Last Updated: December 17, 2010

Additional relevant MeSH terms:
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases processed this record on April 25, 2017