Fructose Malabsorption in Northern Norway - Full Text View

Sponsor:	University Hospital of North Norway
Collaborator:	Nordlandssykehuset HF
Information provided by (Responsible Party):	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:	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:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Malabsorption Syndromes

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:	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

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: 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:

Irritable Bowel Syndrome
Malabsorption Syndromes
Colonic Diseases, Functional
Colonic Diseases

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on February 13, 2012