Irritable Bowel SyndromePhase 2/3FINNNCT00555191
Fructose Malabsorption in Northern Norway
A Phase 2/3 study testing diet restriction in people with Irritable Bowel Syndrome and Fructose Malabsorption, run by University Hospital of North Norway at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Fructose Malabsorption
- What is being tested?
- diet restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2007to May 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS patients satisfying ROME 2 diagnostic criteria
Who cannot join
- Seriously ill
- Organic abdominal disease
- Other functional bowel disease
Trial locations and contacts
1 site in 1 country.
Norway1 site
Hospital of Rana Medical Dep. Helgelandsykehuset HF
Mo i Rana, Nordland, 8607
About this study
Official title: Fructose Malabsorption in Northern Norway. Fructose Malabsorption and Irritable Bowel Syndrome.
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
- Being tested
- diet restriction
- Keywords
- fructose, Irritable bowel syndrome, malabsorption, Glut5 transporter gene
- Medical subject headings
- Irritable Bowel Syndrome, Fructose Intolerance, Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet restrictionBehavioural
each meal should contain less than 2 gm fructose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | PATIENTS IN THIS ARM IS INSTRUCTED IN FRUCTOSE REDUCED DIET FOR A PERIOD OF 3 MONTHS Receives: Behavioral: diet restriction |
| 2 | No intervention | these patients use their usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score og specific abdominal complaints.SGA score of relief related to abdominal complaints.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Nordlandssykehuset HF
- Responsible party
- Sponsor
- Investigators
- Jon Florholmen, MD PhD, Principal investigator, University Hospital of North Norway, Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555191
- Sponsor's protocol ID
- N-136/2006(REK)
- Other IDs
- 2006/136(REK-N), 15567/NSD, Ref 1204 Biobankregisteret
- Acronym
- FINN
- Status last verified
- May 2016
- First submitted
- 6 Nov 2007
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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
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
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructose Malabsorption in Northern Norway. Fructose Malabsorption and Irritable Bowel Syndrome.
- ClinicalTrials.gov ID
- NCT00555191
- Acronym / sponsor ID
- FINN / N-136/2006(REK)
- Conditions
- Irritable Bowel Syndrome, Fructose Malabsorption
- Keywords
- fructose, Irritable bowel syndrome, malabsorption, Glut5 transporter gene
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Nordlandssykehuset HF
- Study start
- Sep 2007
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: diet restrictionPATIENTS IN THIS ARM IS INSTRUCTED IN FRUCTOSE REDUCED DIET FOR A PERIOD OF 3 MONTHS |
| 2 | No intervention | –these patients use their usual diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- IBS patients satisfying ROME 2 diagnostic criteria
Key exclusion criteria (3 listed)
- Seriously ill
- Organic abdominal disease
- Other functional bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diet restrictioneach meal should contain less than 2 gm fructose | Behavioural | 1 |
Primary outcome
VAS score og specific abdominal complaints.SGA score of relief related to abdominal complaints.
Time frame: 12 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Derived from this study: PubMed 25987795Berg 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.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Florholmen, MD PhD principal investigator
University Hospital of North Norway, Department of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing diet restriction in people with Irritable Bowel Syndrome and Fructose Malabsorption, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score og specific abdominal complaints.SGA score of relief related to abdominal complaints. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00555191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.