Fructose Malabsorption in Northern Norway (FINN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University Hospital of North Norway.
Recruitment status was  Active, not recruiting
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
  Purpose

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.


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: March 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
PATIENTS IN THIS ARM IS INSTRUCTED IN FRUCTOSEREDUCED DIET
Behavioral: diet restriction
each meal should contain less than 2 gm fructose
No Intervention: 2
these patients use their usual diet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov 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: November 9, 2011
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:
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

ClinicalTrials.gov processed this record on September 18, 2014