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Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption

NCT ID: NCT00916487

Last Updated: 2010-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Fructose Malabsorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm1

single arm of study in cross-over design

Group Type EXPERIMENTAL

Fructosin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Fructosin

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Frutosin(R)

Eligibility Criteria

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Inclusion Criteria

* diagnosed fructose malabsorption

Exclusion Criteria

* Gravidity
* diabetes mellitus
* recent gastrointestinal surgery
* recent endoscopy
* recent antibiotics therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Austrian Research Promotion Agency

OTHER_GOV

Sponsor Role collaborator

Sciotec Diagnostic Technologies GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Sciotec Diagnostic Technologies GmbH

Principal Investigators

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Peter Komericki, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Christian Pongracz, MS

Role: STUDY_DIRECTOR

Sciotec Diagnostic Technologies GmbH

Locations

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Medical University of Graz

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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Fructo001

Identifier Type: -

Identifier Source: org_study_id

EUDRACT2008-005861-80

Identifier Type: -

Identifier Source: secondary_id