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Fructose Malabsorption in Northern Norway (FINN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Nordlandssykehuset HF
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00555191
First received: November 6, 2007
Last updated: November 9, 2011
Last verified: November 2011
History of Changes

November 6, 2007
November 9, 2011
September 2007
December 2011   (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 ] [ Designated as safety issue: No ]
VAS score og specific abdominal complaints.SGA score of relief related to abdominal complaints. [ Time Frame: 12 weeks ]
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 ] [ Designated as safety issue: No ]
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 ]
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 og 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 FRUCTOSEREDUCED DIET
    Intervention: Behavioral: diet restriction
  • No Intervention: 2
    these patients use their usual diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
March 2013
December 2011   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00555191
N-136/2006(REK), 136/2006/REK-N, 15567/NSD, Ref 1204 Biobankregisteret
No
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
November 2011

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