Trial record 2 of 3 for:    "Acquired fructose intolerance"

Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption

This study has been completed.
Sponsor:
Collaborator:
Austrian Research Promotion Agency
Information provided by:
Sciotec Diagnostic Technologies GmbH
ClinicalTrials.gov Identifier:
NCT00916487
First received: June 5, 2009
Last updated: December 17, 2010
Last verified: December 2010
  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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • diagnosed fructose malabsorption

Exclusion Criteria:

  • Gravidity
  • diabetes mellitus
  • recent gastrointestinal surgery
  • recent endoscopy
  • recent antibiotics therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916487

Locations
Austria
Medical University of Graz
Graz, Styria, Austria, A-8036
Sponsors and Collaborators
Sciotec Diagnostic Technologies GmbH
Austrian Research Promotion Agency
Investigators
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 September 22, 2014