Fructose Malabsorption in Northern Norway - Full Text View

Fructose Malabsorption in Northern Norway (FINN)

This study is currently recruiting participants.

Verified by University Hospital of North Norway, January 2010

First Received: November 6, 2007 Last Updated: January 13, 2010 History of Changes

Sponsor:	University Hospital of North Norway
Collaborators:	Nordlandssykehuset HF Hospital of Vefsn Helgelandsykehuset HF
Information provided by:	University Hospital of North Norway
ClinicalTrials.gov Identifier:	NCT00555191

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Fructose Malabsorption in Northern Norway. Fructose Malabsorption and Irritable Bowel Syndrome.

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Diets

Drug Information available for: Fructose

U.S. FDA Resources

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:	January 2012
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator PATIENTS IN THIS ARM IS INSTRUCTED IN FRUCTOSEREDUCED DIET	Behavioral: diet restriction each meal should contain less than 2 gm fructose
2: No Intervention 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555191

Contacts

Contact: Leif Kyrre Berg, MD	++47750563235	leif.berg@monet.no
Contact: Jon Florholmen, PhD MD	47029198	jon.florholmen@unn.no

Locations

Norway, Nordland
Hospital of Rana Medical Dep. Helgelandsykehuset HF	Recruiting
Mo I Rana, Nordland, Norway, 8607
Contact: Leif Kyrre Berg, MD ++4775056325 leif.berg@monet.no
Principal Investigator: Leif Kyrre Berg, MD

Sponsors and Collaborators

University Hospital of North Norway

Nordlandssykehuset HF

Hospital of Vefsn Helgelandsykehuset HF

Investigators

Principal Investigator:

Jon Florholmen, MD PhD

University Hospital of North Norway, Department of Gastroenterology

More Information

No publications provided

Responsible Party:	Hosptal of Rana Helgelandsykehuset HF ( Leif Kyrre Berg senior consultant Gastroenterology )
Study ID Numbers:	N-136/2006(REK), 136/2006/REK-N, 15567/NSD, Ref 1204 Biobankregisteret
Study First Received:	November 6, 2007
Last Updated:	January 13, 2010
ClinicalTrials.gov Identifier:	NCT00555191 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs

Keywords provided by University Hospital of North Norway:

fructose
Irritable bowel syndrome
malabsorption
Glut5 transporter gene

Additional relevant MeSH terms:

Pathologic Processes
Disease
Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Syndrome

Colonic Diseases
Irritable Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on February 08, 2010