Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 1 of 3 for:    "Acquired fructose intolerance"
Previous Study | Return to List | Next Study

Fructose Malabsorption in Northern Norway (FINN)

This study has been completed.
Nordlandssykehuset HF
Information provided by (Responsible Party):
University Hospital of North Norway Identifier:
First received: November 6, 2007
Last updated: May 23, 2016
Last verified: May 2016

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 ]

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
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   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital of North Norway Identifier: NCT00555191     History of Changes
Other Study ID Numbers: N-136/2006(REK)  2006/136(REK-N)  15567/NSD  Ref 1204 Biobankregisteret 
Study First Received: November 6, 2007
Last Updated: May 23, 2016
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health
Individual Participant Data  
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:
Irritable bowel syndrome
Glut5 transporter gene

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Malabsorption Syndromes
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases processed this record on October 26, 2016