Fructose MalabsorptionNCT00916487
Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption
A study testing Fructosin in people with Fructose Malabsorption, run by Sciotec Diagnostic Technologies GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fructose Malabsorption
- What is being tested?
- Fructosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed fructose malabsorption
Who cannot join
- Gravidity
- diabetes mellitus
- recent gastrointestinal surgery
- recent endoscopy
- recent antibiotics therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Fructose Metabolizing Enzymatic Product Fructosin(R) in Patients With 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.
Read the 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.
- Conditions
- Fructose Malabsorption
- Being tested
- Fructosin
- Medical subject headings
- Fructose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FructosinDietary supplement
Also called Frutosin(R)
Three capsules of Fructosin before one of the hydrogen breath tests.
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | single arm of study in cross-over design Receives: Dietary Supplement: Fructosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve (AUC) of the exhaled breath hydrogen in ppm*min
Measured: 4 hours
Secondary outcomes (1)
Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fructose MalabsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciotec Diagnostic Technologies GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Austrian Research Promotion Agency
- Investigators
- Peter Komericki, MD, Principal investigator, Medical University of GrazChristian Pongracz, MS, Study director, Sciotec Diagnostic Technologies GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916487
- Sponsor's protocol ID
- Fructo001
- Other IDs
- EUDRACT2008-005861-80
- Status last verified
- Dec 2010
- First submitted
- 5 Jun 2009
- Last updated
- 20 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fructose Metabolizing Enzymatic Product Fructosin(R) in Patients With Fructose Malabsorption
- ClinicalTrials.gov ID
- NCT00916487
- Acronym / sponsor ID
- Fructo001
- Conditions
- Fructose Malabsorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Sciotec Diagnostic Technologies GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Austrian Research Promotion Agency
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Dietary Supplement: Fructosinsingle arm of study in cross-over design |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed fructose malabsorption
Key exclusion criteria (5 listed)
- Gravidity
- diabetes mellitus
- recent gastrointestinal surgery
- recent endoscopy
- recent antibiotics therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FructosinAlso: Frutosin(R)Three capsules of Fructosin before one of the hydrogen breath tests. | Dietary supplement | Arm1 |
Primary outcome
area under the curve (AUC) of the exhaled breath hydrogen in ppm*min
Time frame: 4 hours
1 secondary outcome
Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2010.
Related trials for Fructose Malabsorption
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New Microbiota-endocrine Axis in Fructose Malabsorption-caused Visceral Hypersensitivity in Irritable Bowel Syndrome.
Irritable Bowel Syndrome (IBS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Komericki, MD principal investigator
Medical University of Graz
Christian Pongracz, MS study director
Sciotec Diagnostic Technologies GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructosin in people with Fructose Malabsorption, run by Sciotec Diagnostic Technologies GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area under the curve (AUC) of the exhaled breath hydrogen in ppm*min (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2010.