Long Term Follow up on Functional Gastrointestinal Disord... | NCT02689648

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

NCT02689648

Sponsor

Umeå University

Status

Completed

Last Update Posted

May 28, 2026Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Functional Gastrointestinal Disorder

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Jan 2025Actual

Completion Date

May 2025Actual

First Submitted Date

Feb 8, 2016

First Submission Date that Met QC Criteria

Feb 23, 2016

First Posted Date

Feb 24, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2026

Last Update Posted Date

May 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Staffan K Berglund	Umeå University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Umeå University, Department of Clinical Sciences		Umeå	Umeå	90185	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005767	Gastrointestinal Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided