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Completed

NCT Number: NCT00916487

Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption

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.

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Key information

Conditions

Fructose Malabsorption Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fructose Intolerance Fructose Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, Styria, A-8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed fructose malabsorption

Exclusion criteria

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

Treatment and study plan

Fructosin

Dietary Supplement

Three capsules of Fructosin before one of the hydrogen breath tests.

Other names: Frutosin(R)

Primary outcomes

  1. area under the curve (AUC) of the exhaled breath hydrogen in ppm*min

    Time frame: 4 hours

Secondary outcomes

  1. Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation)

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Sciotec Diagnostic Technologies GmbH

Industry

Collaborators

  • Austrian Research Promotion Agency

Registry information

Official study title

Efficacy of Fructose Metabolizing Enzymatic Product Fructosin(R) in Patients With Fructose Malabsorption

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 9, 2009
Registry last updated
Dec 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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