NCT04859972

Brief Summary

The aim of this project is to investigate the implementation of the Rome criteria in daily primary care clinical practice and adherence of general practitioners (GPs) to recommended diagnostic approaches for IBS.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

November 22, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

November 23, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

April 22, 2021

Last Update Submit

November 22, 2021

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeRome IVFunctional gastrointestinal disorders

Outcome Measures

Primary Outcomes (1)

  • Adherence to guidelines of making a positive diagnosis of IBS within primary care.

    The proportion of patients that received a positive IBS diagnosis versus the proportion of patients that received a negative IBS diagnosis.

    2015-2019

Secondary Outcomes (4)

  • Prevalence of diarrhea-predominant IBS and IBS without diarrhea.

    2015-2019

  • The proportion of IBS patients that have one or more comorbidities.

    2015-2019

  • The proportion of IBS patients with post-infectious IBS.

    2015-2019

  • The proportion of IBS patients with substance abuse.

    2015-2019

Study Arms (1)

Patients diagnosed with IBS

Patients diagnosed with IBS within primary care in Region Örebro County between 2015- 2019, identified by ICD-code K.58.

Diagnostic Test: Diagnosis of IBS

Interventions

Diagnosis of IBSDIAGNOSTIC_TEST

Diagnosis of IBS according to ICD-10

Patients diagnosed with IBS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with IBS within primary care of Region Örebro County 2015-2019.

You may qualify if:

  • All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 in Region Örebro County 2015-2019.

You may not qualify if:

  • Patients \< 18 years or \> 65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Irritable Bowel SyndromeGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesDigestive System Diseases

Study Officials

  • Michiel van Nieuwenhoven, Associate Professor, M.D. PhD.

    Region Örebro County

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jussi Rauma, Ph.D. student, M.D.

CONTACT

+46702484167jussi.rauma@regionorebrolan.se

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 26, 2021

Study Start

November 22, 2021

Primary Completion

August 1, 2022

Study Completion

May 1, 2023

Last Updated

November 23, 2021

Record last verified: 2021-03