Fructose Malabsorption in Northern Norway

NCT00555191 | Completed Phase 2

• 4 other identifiers: N-136/2006(REK)2006/136(REK-N)15567/NSDRef 1204 Biobankregisteret
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Fructose Malabsorption

Keywords

fructose; Irritable bowel syndrome; malabsorption; Glut5 transporter gene

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

Behavioral: diet restriction

2

NO INTERVENTION

these patients use their usual diet

Interventions

diet restriction BEHAVIORAL

each meal should contain less than 2 gm fructose

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IBS patients satisfying ROME 2 diagnostic criteria

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• Nordlandssykehuset HF: collaborator

Study Sites (1)

Hospital of Rana Medical Dep. Helgelandsykehuset HF

Mo i Rana, Nordland, 8607, Norway

Location

Related Publications (1)

• 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.

  PMID: 25987795 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Fructose Intolerance; Malabsorption Syndromes

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Fructose Metabolism, Inborn Errors; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jon Florholmen, MD PhD

  University Hospital of North Norway, Department of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2007
• First Posted: November 8, 2007
• Study Start: September 1, 2007
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 24, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)