Functional Gastrointestinal DisorderLUFTNCT02689648
Long Term Follow up on Functional Gastrointestinal Disorder (FGID)
An observational study of Functional Gastrointestinal Disorder, run by Umeå University at 1 site in Sweden.
Trial summary
Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is largely unknown. The investigators plan to retrospectively analyse a cohort of children who were referred to the Pediatric Clinic due to abdominal pain with the aims to learn more about symptoms and effects of investigations… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Functional Gastrointestinal Disorder
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2016to May 2025
- Phase
- Observational
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children between 3 and 18 years of age that were refereed to the Pediatric Clinic of Västerbotten county council during the years 2009-2015.
At time of first visit the children had:
- At least 2 months of abdominal pain
- Age 3-18 years
- No organic gastrointestinal diseases
- No neuromuscular disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Umeå University, Department of Clinical Sciences
Umeå, Umeå, 90185
About this study
Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is largely unknown. The investigators plan to retrospectively analyse a cohort of children who were referred to the Pediatric Clinic due to abdominal pain with the aims to learn more about symptoms and effects of investigations performed. Furthermore, the investigators plan to contact the cases for a follow up using a validated questionnaire and analyse the long term prognosis and risk factors for prolonged severe symptoms.
Read the detailed description
Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is largely unknown. The investigators plan to retrospectively analyse a cohort of children who during the years 2010-2015 were referred to the Pediatric Clinic of Umeå University Hospital due to abdominal pain. The aims are to explore and descriptively describe the symptoms and effects of investigations performed. Furthermore, the investigators plan to contact the cases five years after the first contact for a follow up using a validated questionnaire of the ROME-III-criteria and analyse the long term prognosis and risk factors for prolonged severe symptoms.
- Conditions
- Functional Gastrointestinal Disorder
- Medical subject headings
- Gastrointestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of patients that fulfill the ROME-III criteria for FGID
Measured by the validated ROME-III questionnaire
Measured: 5 years after fist visit +/- 1 year
Secondary outcomes (3)
ICD 10-diagnosis following the primary investigation
Measured: 12 months after first visit
Current ICD 10-diagnosis
Measured: 5 years after fist visit +/- 1 year
Number (n) of visits for the primary investigations
Measured: 0-12 months after first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2025
- Study completionMay 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisorderStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staffan Berglund, Umeå University
- Investigators
- Staffan K Berglund, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689648
- Sponsor's protocol ID
- LUFT2016
- Acronym
- LUFT
- Status last verified
- May 2025
- First submitted
- 8 Feb 2016
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up on Functional Gastrointestinal Disorder (FGID)
- ClinicalTrials.gov ID
- NCT02689648
- Acronym / sponsor ID
- LUFT / LUFT2016
- Conditions
- Functional Gastrointestinal Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jan 2025 (actual)
- Study completion
- May 2025 (actual)
- First posted
- 24 Feb 2016 (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.
Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is largely unknown. The investigators plan to retrospectively analyse a cohort of children who were referred to the Pediatric Clinic due to abdominal pain with the aims to learn more about symptoms and effects of investigations performed. Furthermore, the investigators plan to contact the cases for a follow up using a validated questionnaire and analyse the long term prognosis and risk factors for prolonged severe symptoms.
Detailed description
Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is largely unknown. The investigators plan to retrospectively analyse a cohort of children who during the years 2010-2015 were referred to the Pediatric Clinic of Umeå University Hospital due to abdominal pain. The aims are to explore and descriptively describe the symptoms and effects of investigations performed. Furthermore, the investigators plan to contact the cases five years after the first contact for a follow up using a validated questionnaire of the ROME-III-criteria and analyse the long term prognosis and risk factors for prolonged severe symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children between 3 and 18 years of age that were refereed to the Pediatric Clinic of Västerbotten county council during the years 2009-2015.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage (%) of patients that fulfill the ROME-III criteria for FGID
Time frame: 5 years after fist visit +/- 1 year
Measured by the validated ROME-III questionnaire
3 secondary outcomes
ICD 10-diagnosis following the primary investigation
Time frame: 12 months after first visit
Current ICD 10-diagnosis
Time frame: 5 years after fist visit +/- 1 year
Number (n) of visits for the primary investigations
Time frame: 0-12 months after first visit
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 28 May 2026.
- Individual participant dataSharing planned: No
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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.
Staffan K Berglund principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorder, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 May 2026. 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 Sweden. 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.
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?
Percentage (%) of patients that fulfill the ROME-III criteria for FGID (time frame: 5 years after fist visit +/- 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.