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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
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 6, 2007
Last Updated
May 23, 2016
Sponsor
University Hospital of North Norway
Collaborators
Nordlandssykehuset HF
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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

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Fructose Malabsorption in Northern Norway

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