NCT05144581

Brief Summary

The purpose of this study is to retrospectively evaluate treatment strategies for IBS used within primary Health care in Örebro Region.

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

Typical duration for all trials

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

November 22, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

November 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

November 22, 2021

Last Update Submit

November 22, 2021

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndromeFunctional gastrointestinal disorders

Outcome Measures

Primary Outcomes (2)

  • Adherence to guidelines of pharmacological treatment of IBS within primary care

    The proportion of patients that have received pharmacological treatment according to guidelines for IBS within primary care.

    2013-2017

  • Adherence to guidelines of non-pharmacological treatment of IBS within primary care

    The proportion of patients that have received non-pharmacological treatment according to guidelines for IBS within primary care.

    2013-2017

Secondary Outcomes (2)

  • Efficacy of treatment of IBS

    2013-2017

  • Use of inappropriate treatments of IBS

    2013-2017

Study Arms (1)

Patients diagnosed with IBS

Patients diagnosed with IBS within primary care in Region Örebro County 2013-2017, identified by ICD-code K.58.

Eligibility Criteria

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

Patients diagnosed with IBS within primary care of Region Örebro County 2013-2017.

You may qualify if:

  • All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 in Region Örebro County 2013-2017.

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, M.D. Ph.D.

    Region Örebro County

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jussi Rauma, M.D.

CONTACT

+460702484167jussi.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

November 22, 2021

First Posted

December 3, 2021

Study Start

November 29, 2021

Primary Completion

May 31, 2023

Study Completion

May 31, 2024

Last Updated

December 3, 2021

Record last verified: 2021-11