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Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00916487
Enrollment
65
Registered
2009-06-09
Start date
2009-06-30
Completion date
2010-08-31
Last updated
2010-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fructose Malabsorption

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.

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.

Interventions

DIETARY_SUPPLEMENTFructosin

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

Sponsors

Austrian Research Promotion Agency
CollaboratorOTHER_GOV
Sciotec Diagnostic Technologies GmbH
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* diagnosed fructose malabsorption

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
area under the curve (AUC) of the exhaled breath hydrogen in ppm*min4 hours

Secondary

MeasureTime frame
Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation)24 hours

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026