Long Term Follow up on Functional Gastrointestinal Disorder (FGID)

Active, not recruiting

• Conditions: Functional Gastrointestinal Disorder

• Registration Number: NCT02689648
• Lead Sponsor: Umeå University

Brief 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 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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Umeå University, Department of Clinical Sciences; 🇸🇪 Umeå, Sweden