Irritable Bowel SyndromeNCT01705171
Is the Expression of the GLUT5 Specific Fructose Transport Protein Abnormal in Patients With Fructose Intolerance?
An observational study of Irritable Bowel Syndrome and Fructose Intolerance, run by Brain-Gut Research Group at 1 site in Switzerland.
Trial summary
In this study we will investigate the expression of the fructose transport protein GLUT5 in the small intestine in patients with functional GI disoders and fructose intolerance compared to matched healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Fructose Intolerance
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2011to Oct 2013
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients referred to our practice for evaluation of symptoms consistent with FGID undergoing upper GI endoscopy with biopsy and fructose breath testing as part of their usual clinical evaluation.
Who may be able to join
- Patients referred to our practice for evaluation of symptoms consistent with FGID undergoing upper GI endoscopy with biopsy and fructose breath testing as part of their usual clinical evaluation. Male or female patients aged between 18 and 60 years with FGID (Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD) or Functional Bloating (FB), as defined by Rome III criteria.
- Successive patients without fructose intolerance undergoing upper GI endoscopy for other reasons without inflammatory disease
Who cannot join
- Inflammatory GI disease, coeliac's disease, other relevant systemic disorders as judged by investigator, concomitant antiinflammtory treatments, absent informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
In this study we will investigate the expression of the fructose transport protein GLUT5 in the small intestine in patients with functional GI disoders and fructose intolerance compared to matched healthy controls.
Read the detailed description
Intolerances to food are a major complaint of patients with functional gastrointestinal disorders (FGID) and even commoner in patients with inflammatory bowel disorders (IBD) (Barrett JS et al. Aliment Pharmacol Therap 2009;30:165-174). The most common forms of food intolerance are FODMAP (fermentable oligo-, di- and monosaccharide and polyol) -related, of which fructose and lactose are the best known. The prevalence of lactose and fructose intolerance in IBS patients is between 50 and 70% (Wilder-Smith CH et al. Gastroenterology 2009;136 (Suppl. 1): A324). Recent high quality studies have shown that the reduction of ingested FODMAP can lead to significant and long-term symptom improvement in patients shown to be intolerant by breath-testing. While the pathophysiology behind lactose intolerance is the reduction in small intestinal lactase availability, the mechanism in fructose intolerance and its relationship to malabsorption are unknown. One possible and so far uninvestigated mechanism is a reduction in the expression or activity of the specific fructose transporter, GLUT5, which is mainly responsible for luminal absorption of fructose. GLUT5 is mainly found in the small intestine, as well as various extra-intestinal organs. The clinical relevance of GLUT5 expression for food intolerances in humans has not been reported, but in a mouse model deletion of GLUT5 led to decreased absorption of dietary fructose and typical signs of malabsorption (Barone S et al. J Biol Chem 2009;284:5056-5066). The control of GLUT5 is dynamic and considerable upregulation together with increased absorption of fructose is evident in diabetes mellitus, while expression is decreased by inflammation and lipopolysaccharide endotoxin, an integral component of the outer membrane of all gram-negative bacteria, through the action of pro-inflammatory cytokines, such as TFN-a.
- Conditions
- Irritable Bowel Syndrome, Fructose Intolerance
- Keywords
- IBS, fructose intolerance, GLUT 5, GLUT 2
- Medical subject headings
- Irritable Bowel Syndrome, Fructose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBS patients with fructose intolerance | analysis of biopsies | |
| Control group: no IBS or fructose intolerance | analysis of biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA and protein expression of Glut5
Measured: on day of endoscopy
Secondary outcomes (1)
mRNA and protein expression of Glut2
Measured: on day of endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startDec 2011
- Primary completionMay 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain-Gut Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C. Wilder-Smith, Brain-Gut Research Group
- Investigators
- C Wilder-Smith, MD, Principal investigator, Brain-Gut Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705171
- Sponsor's protocol ID
- GGP1345012
- Other IDs
- GLUT5
- Status last verified
- Dec 2018
- First submitted
- 9 Oct 2012
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Expression of the GLUT5 Specific Fructose Transport Protein Abnormal in Patients With Fructose Intolerance?
- ClinicalTrials.gov ID
- NCT01705171
- Acronym / sponsor ID
- GGP1345012
- Conditions
- Irritable Bowel Syndrome, Fructose Intolerance
- Keywords
- IBS, fructose intolerance, GLUT 5, GLUT 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Brain-Gut Research GroupUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 Oct 2012 (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.
In this study we will investigate the expression of the fructose transport protein GLUT5 in the small intestine in patients with functional GI disoders and fructose intolerance compared to matched healthy controls.
Detailed description
Intolerances to food are a major complaint of patients with functional gastrointestinal disorders (FGID) and even commoner in patients with inflammatory bowel disorders (IBD) (Barrett JS et al. Aliment Pharmacol Therap 2009;30:165-174). The most common forms of food intolerance are FODMAP (fermentable oligo-, di- and monosaccharide and polyol) -related, of which fructose and lactose are the best known. The prevalence of lactose and fructose intolerance in IBS patients is between 50 and 70% (Wilder-Smith CH et al. Gastroenterology 2009;136 (Suppl. 1): A324). Recent high quality studies have shown that the reduction of ingested FODMAP can lead to significant and long-term symptom improvement in patients shown to be intolerant by breath-testing. While the pathophysiology behind lactose intolerance is the reduction in small intestinal lactase availability, the mechanism in fructose intolerance and its relationship to malabsorption are unknown. One possible and so far uninvestigated mechanism is a reduction in the expression or activity of the specific fructose transporter, GLUT5, which is mainly responsible for luminal absorption of fructose. GLUT5 is mainly found in the small intestine, as well as various extra-intestinal organs. The clinical relevance of GLUT5 expression for food intolerances in humans has not been reported, but in a mouse model deletion of GLUT5 led to decreased absorption of dietary fructose and typical signs of malabsorption (Barone S et al. J Biol Chem 2009;284:5056-5066). The control of GLUT5 is dynamic and considerable upregulation together with increased absorption of fructose is evident in diabetes mellitus, while expression is decreased by inflammation and lipopolysaccharide endotoxin, an integral component of the outer membrane of all gram-negative bacteria, through the action of pro-inflammatory cytokines, such as TFN-a.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS patients with fructose intolerance | – | –analysis of biopsies |
| Control group: no IBS or fructose intolerance | – | –analysis of biopsies |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients referred to our practice for evaluation of symptoms consistent with FGID undergoing upper GI endoscopy with biopsy and fructose breath testing as part of their usual clinical evaluation.
Key inclusion criteria (2 listed)
- Patients referred to our practice for evaluation of symptoms consistent with FGID undergoing upper GI endoscopy with biopsy and fructose breath testing as part of their usual clinical evaluation. Male or female patients aged between 18 and 60 years with FGID (Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD) or Functional Bloating (FB), as defined by Rome III criteria.
- Successive patients without fructose intolerance undergoing upper GI endoscopy for other reasons without inflammatory disease
Key exclusion criteria (1 listed)
- Inflammatory GI disease, coeliac's disease, other relevant systemic disorders as judged by investigator, concomitant antiinflammtory treatments, absent informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mRNA and protein expression of Glut5
Time frame: on day of endoscopy
1 secondary outcome
mRNA and protein expression of Glut2
Time frame: on day of endoscopy
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 17 Dec 2018.
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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.
C Wilder-Smith, MD principal investigator
Brain-Gut Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome and Fructose Intolerance, run by Brain-Gut Research Group at 1 site in Switzerland.
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 2 inclusion and 1 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 17 Dec 2018. 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 Switzerland. 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?
mRNA and protein expression of Glut5 (time frame: on day of endoscopy). 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 17 Dec 2018.