NCT00916487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 20, 2010

Status Verified

December 1, 2010

Enrollment Period

11 months

First QC Date

June 5, 2009

Last Update Submit

December 17, 2010

Conditions

Fructose Malabsorption

Outcome Measures

Primary Outcomes (1)

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

    4 hours

Secondary Outcomes (1)

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

    24 hours

Study Arms (1)

Arm1

EXPERIMENTAL

single arm of study in cross-over design

Dietary Supplement: Fructosin

Interventions

FructosinDIETARY_SUPPLEMENT

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

Also known as: Frutosin(R)
Arm1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed fructose malabsorption

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, A-8036, Austria

Location

MeSH Terms

Conditions

Fructose Intolerance

Condition Hierarchy (Ancestors)

Fructose Metabolism, Inborn ErrorsCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Peter Komericki, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

  • Christian Pongracz, MS

    Sciotec Diagnostic Technologies GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 9, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2010

Study Completion

August 1, 2010

Last Updated

December 20, 2010

Record last verified: 2010-12

Locations

AU(1)