NCT01705171

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2011

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

December 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 17, 2018

Status Verified

December 1, 2018

Enrollment Period

1.4 years

First QC Date

October 9, 2012

Last Update Submit

December 14, 2018

Conditions

Keywords

IBSfructose intoleranceGLUT 5GLUT 2

Outcome Measures

Primary Outcomes (1)

  • mRNA and protein expression of Glut5

    on day of endoscopy

Secondary Outcomes (1)

  • mRNA and protein expression of Glut2

    on day of endoscopy

Study Arms (2)

IBS patients with fructose intolerance

analysis of biopsies

Control group: no IBS or fructose intolerance

analysis of biopsies

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Inflammatory GI disease, coeliac's disease, other relevant systemic disorders as judged by investigator, concomitant antiinflammtory treatments, absent informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastoenterology Group Practice

Bern, Switzerland

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeFructose Intolerance

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesFructose Metabolism, Inborn ErrorsCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • C Wilder-Smith, MD

    Brain-Gut Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 12, 2012

Study Start

December 1, 2011

Primary Completion

May 1, 2013

Study Completion

October 1, 2013

Last Updated

December 17, 2018

Record last verified: 2018-12

Locations