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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
November 6, 2007
November 8, 2007
May 24, 2016
September 2007
May 2016   (Final data collection date for primary outcome measure)
VAS score og specific abdominal complaints.SGA score of relief related to abdominal complaints. [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00555191 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Fructose Malabsorption in Northern Norway
Fructose Malabsorption in Northern Norway. Fructose Malabsorption and Irritable Bowel Syndrome.

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Irritable Bowel Syndrome
  • Fructose Malabsorption
Behavioral: diet restriction
each meal should contain less than 2 gm fructose
  • Active Comparator: 1
    PATIENTS IN THIS ARM IS INSTRUCTED IN FRUCTOSE REDUCED DIET FOR A PERIOD OF 3 MONTHS
    Intervention: Behavioral: diet restriction
  • No Intervention: 2
    these patients use their usual diet
Berg LK, Fagerli E, Myhre AO, Florholmen J, Goll R. Self-reported dietary fructose intolerance in irritable bowel syndrome: Proposed diagnostic criteria. World J Gastroenterol. 2015 May 14;21(18):5677-84. doi: 10.3748/wjg.v21.i18.5677.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
May 2016
May 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • IBS patients satisfying ROME 2 diagnostic criteria

Exclusion Criteria:

  • Seriously ill
  • Organic abdominal disease
  • Other functional bowel disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00555191
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 )
No
Not Provided
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
University Hospital of North Norway
University Hospital of North Norway
Nordlandssykehuset HF
Principal Investigator: Jon Florholmen, MD PhD University Hospital of North Norway, Department of Gastroenterology
University Hospital of North Norway
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP