Long Term Follow up on Functional Gastrointestinal Disorder (FGID)

Functional Gastrointestinal Disorder Clinical Trial

— LUFT  

Official title:

Long Term Follow up on Functional Gastrointestinal Disorder (FGID)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02689648
• Other study ID #: LUFT2016
• Status: Active, not recruiting
• Start date: February 2016
• Est. completion date: January 2027

Study information

• Verified date: May 2024
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: January 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorder
• Gastrointestinal Diseases

Locations

Country	Name	City	State
Sweden	Umeå University, Department of Clinical Sciences	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ICD 10-diagnosis following the primary investigation		12 months after first visit
Secondary	Current ICD 10-diagnosis		5 years after fist visit +/- 1 year
Secondary	Number (n) of visits for the primary investigations		0-12 months after first visit