Long Term Follow up on Functional Gastrointestinal Disorder (FGID) (LUFT)

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.

Study Overview

• Status: Recruiting
• Conditions: Functional Gastrointestinal Disorder

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Staffan K Berglund; Phone Number: +46703956767; Email: staffan.berglund@umu.se

Study Locations

• Sweden
  • Umeå, Sweden, 90185
    • Recruiting
    • Umeå University, Department of Clinical Sciences
    • Contact: Staffan K Berglund, MD, PhD; Phone Number: +46703956767; Email: staffan.berglund@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

At time of first visit the children had:

1. At least 2 months of abdominal pain
2. Age 3-18 years
3. No organic gastrointestinal diseases
4. No neuromuscular disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage (%) of patients that fulfill the ROME-III criteria for FGID	Measured by the validated ROME-III questionnaire	5 years after fist visit +/- 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
ICD 10-diagnosis following the primary investigation	12 months after first visit
Current ICD 10-diagnosis	5 years after fist visit +/- 1 year
Number (n) of visits for the primary investigations	0-12 months after first visit

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Staffan K Berglund, Umea University

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: February 8, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: LUFT2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO