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Fructose Malabsorption in Northern Norway (FINN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555191
First Posted: November 8, 2007
Last Update Posted: May 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nordlandssykehuset HF
Information provided by (Responsible Party):
University Hospital of North Norway
  Purpose

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 Intervention Phase
Irritable Bowel Syndrome Fructose Malabsorption Behavioral: diet restriction Phase 2 Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 182
Study Start Date: September 2007
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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 Submitted: November 6, 2007
First Posted: November 8, 2007
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