Fructose Malabsorption in Northern Norway (FINN)

This study is ongoing, but not recruiting participants.
Nordlandssykehuset HF
Information provided by (Responsible Party):
University Hospital of North Norway Identifier:
First received: November 6, 2007
Last updated: December 11, 2014
Last verified: December 2014

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Behavioral: diet restriction
each meal should contain less than 2 gm fructose
No Intervention: 2
these patients use their usual diet


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • IBS patients satisfying ROME 2 diagnostic criteria

Exclusion Criteria:

  • Seriously ill
  • Organic abdominal disease
  • Other functional bowel disease
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Please refer to this study by its identifier: NCT00555191

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

No publications provided

Responsible Party: University Hospital of North Norway Identifier: NCT00555191     History of Changes
Other Study ID Numbers: N-136/2006(REK), 136/2006/REK-N, 15567/NSD, Ref 1204 Biobankregisteret
Study First Received: November 6, 2007
Last Updated: December 11, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

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

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Malabsorption Syndromes
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Metabolic Diseases processed this record on March 26, 2015