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Fructose Malabsorption in Northern Norway (FINN)

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ClinicalTrials.gov Identifier: NCT00555191
Recruitment Status : Completed
First Posted : November 8, 2007
Last Update Posted : May 24, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Different published studies has shown a possible co-variation between leakage of fructose to the great bowel and exacerbation of irritable bowel syndrome (IBS) symptoms.

The aim of the FINN trial is to study the role of fructose malabsorption in patients with IBS in order to evaluate different diagnostic criteria for fructose malabsorption and at the same time study the effect of diet treatment in this cohort of patients and estimate the prevalence of fructose malabsorption.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Fructose Malabsorption Behavioral: diet restriction Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fructose Malabsorption in Northern Norway. Fructose Malabsorption and Irritable Bowel Syndrome.
Study Start Date : September 2007
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
PATIENTS IN THIS ARM IS INSTRUCTED IN FRUCTOSE REDUCED DIET FOR A PERIOD OF 3 MONTHS
Behavioral: diet restriction
each meal should contain less than 2 gm fructose
No Intervention: 2
these patients use their usual diet


Outcome Measures

Primary Outcome Measures :
  1. VAS score og specific abdominal complaints.SGA score of relief related to abdominal complaints. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Estimate sensitivity,specificity,negative and positive predictive value using 50 gm fructose in breath test.Validate questionary for intolerance.Validate VAS in judging changes in abdominal complaint.Examine polymorphism i Glut5 transporter gene. [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IBS patients satisfying ROME 2 diagnostic criteria

Exclusion Criteria:

  • Seriously ill
  • Organic abdominal disease
  • Other functional bowel disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555191


Locations
Norway
Hospital of Rana Medical Dep. Helgelandsykehuset HF
Mo i Rana, Nordland, Norway, 8607
Sponsors and Collaborators
University Hospital of North Norway
Nordlandssykehuset HF
Investigators
Principal Investigator: Jon Florholmen, MD PhD University Hospital of North Norway, Department of Gastroenterology
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00555191     History of Changes
Other Study ID Numbers: N-136/2006(REK)
2006/136(REK-N) ( Registry Identifier: Regional ethic comittee, REK-Nord )
15567/NSD ( Other Identifier: Norsk samfinnsvitenskapelig datatjeneste )
Ref 1204 Biobankregisteret ( Registry Identifier: Biobankregisteret )
First Posted: November 8, 2007    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data already published in two articles published in Scandinavian Journal of Gastroenterology 2013 48: 936-943 DOI: 10.2109/00365521.2013.812139 andWorld Journal of Gastroenterology 2015 May 14;21(18) 5445-5754 DOI: 10.3748/ wjg.v21.i18.5677

Keywords provided by University Hospital of North Norway:
fructose
Irritable bowel syndrome
malabsorption
Glut5 transporter gene

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Malabsorption Syndromes
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases