Fructose Malabsorption in Northern Norway (FINN)
Primary Purpose
Irritable Bowel Syndrome, Fructose Malabsorption
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
diet restriction
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring fructose, Irritable bowel syndrome, malabsorption, Glut5 transporter gene
Eligibility Criteria
Inclusion Criteria:
- IBS patients satisfying ROME 2 diagnostic criteria
Exclusion Criteria:
- Seriously ill
- Organic abdominal disease
- Other functional bowel disease
Sites / Locations
- Hospital of Rana Medical Dep. Helgelandsykehuset HF
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
PATIENTS IN THIS ARM IS INSTRUCTED IN FRUCTOSE REDUCED DIET FOR A PERIOD OF 3 MONTHS
these patients use their usual diet
Outcomes
Primary Outcome Measures
VAS score og specific abdominal complaints.SGA score of relief related to abdominal complaints.
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.
Full Information
NCT ID
NCT00555191
First Posted
November 6, 2007
Last Updated
May 23, 2016
Sponsor
University Hospital of North Norway
Collaborators
Nordlandssykehuset HF
1. Study Identification
Unique Protocol Identification Number
NCT00555191
Brief Title
Fructose Malabsorption in Northern Norway
Acronym
FINN
Official Title
Fructose Malabsorption in Northern Norway. Fructose Malabsorption and Irritable Bowel Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
Nordlandssykehuset HF
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Fructose Malabsorption
Keywords
fructose, Irritable bowel syndrome, malabsorption, Glut5 transporter gene
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
PATIENTS IN THIS ARM IS INSTRUCTED IN FRUCTOSE REDUCED DIET FOR A PERIOD OF 3 MONTHS
Arm Title
2
Arm Type
No Intervention
Arm Description
these patients use their usual diet
Intervention Type
Behavioral
Intervention Name(s)
diet restriction
Intervention Description
each meal should contain less than 2 gm fructose
Primary Outcome Measure Information:
Title
VAS score og specific abdominal complaints.SGA score of relief related to abdominal complaints.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IBS patients satisfying ROME 2 diagnostic criteria
Exclusion Criteria:
Seriously ill
Organic abdominal disease
Other functional bowel disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Florholmen, MD PhD
Organizational Affiliation
University Hospital of North Norway, Department of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Rana Medical Dep. Helgelandsykehuset HF
City
Mo i Rana
State/Province
Nordland
ZIP/Postal Code
8607
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
25987795
Citation
Berg LK, Fagerli E, Myhre AO, Florholmen J, Goll R. Self-reported dietary fructose intolerance in irritable bowel syndrome: Proposed diagnostic criteria. World J Gastroenterol. 2015 May 14;21(18):5677-84. doi: 10.3748/wjg.v21.i18.5677.
Results Reference
derived
Learn more about this trial
Fructose Malabsorption in Northern Norway
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