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NCT00555191 Clinical Trial

Fructose Malabsorption in Northern Norway

Irritable Bowel Syndrome Clinical Trial

— FINN  

Official title:
Fructose Malabsorption in Northern Norway. Fructose Malabsorption and Irritable Bowel Syndrome.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00555191
Other study ID # N-136/2006(REK)
Secondary ID 2006/136(REK-N)1
Status Completed
Phase Phase 2/Phase 3
First received November 6, 2007
Last updated May 23, 2016
Start date September 2007
Est. completion date May 2016

Study information
Verified date May 2016
Source University Hospital of North Norway
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data ServicesNorway: Directorate of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 182
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- IBS patients satisfying ROME 2 diagnostic criteria

Exclusion Criteria:

- Seriously ill

- Organic abdominal disease

- Other functional bowel disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• diet restriction
each meal should contain less than 2 gm fructose

Locations
Country Name City State
Norway Hospital of Rana Medical Dep. Helgelandsykehuset HF Mo i Rana Nordland

Sponsors (2)
Lead Sponsor Collaborator
University Hospital of North Norway Nordlandssykehuset HF

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary VAS score og specific abdominal complaints.SGA score of relief related to abdominal complaints. 12 weeks No
Secondary 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. 12 weeks No
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