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CompletedNCT00555191FINNUpdated May 24, 2016

Fructose Malabsorption in Northern Norway

A Phase 2/3 interventional study of diet restriction in Irritable Bowel Syndrome and Fructose Malabsorption, sponsored by University Hospital of North Norway. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-24.

Sponsored by University Hospital of North Norway · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Irritable Bowel Syndrome
  • Fructose Malabsorption

Keywords

  • fructose
  • Irritable bowel syndrome
  • malabsorption
  • Glut5 transporter gene
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 182 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

University Hospital of North Norway is the lead sponsor of 151 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • IBS patients satisfying ROME 2 diagnostic criteria

Exclusion criteria

Exclusion Criteria:

  • Seriously ill
  • Organic abdominal disease
  • Other functional bowel disease
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
182 participants (actual)

Study arms

  • Active comparator
    1

    PATIENTS IN THIS ARM IS INSTRUCTED IN FRUCTOSE REDUCED DIET FOR A PERIOD OF 3 MONTHS

    Behavioral: diet restriction

  • No intervention
    2

    these patients use their usual diet

Interventions

  • Behavioraldiet restriction

    each meal should contain less than 2 gm fructose

06

What researchers measure

Primary outcomes

  1. VAS score og specific abdominal complaints.SGA score of relief related to abdominal complaints.

    Time frame: 12 weeks

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Hospital of Rana Medical Dep. Helgelandsykehuset HF
    Mo i Rana, Nordland 8607, Norway
08

References and documents

Publications

  • 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. PubMed 25987795 ↗

Individual participant data

Plan to share: Yes — 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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00555191
Lead sponsor
University Hospital of North Norway
Collaborators
Nordlandssykehuset HF
Responsible party
Sponsor
First posted
Nov 8, 2007
Start date
Sep 2007
Primary completion
May 2016
Completion
May 2016
Last update
May 24, 2016

Study contacts

Jon Florholmen, MD PhD
principal investigator · University Hospital of North Norway, Department of Gastroenterology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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