Irritable Bowel SyndromeNCT05144581
Treatment of IBS in Primary Health Care.
An observational study of Irritable Bowel Syndrome, run by Region Örebro County.
Trial summary
The purpose of this study is to retrospectively evaluate treatment strategies for IBS used within primary Health care in Örebro Region. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2021to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with IBS within primary care of Region Örebro County 2013-2017.
Who may be able to join
- All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 in Region Örebro County 2013-2017.
Who cannot join
- Patients < 18 years or > 65 years.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Treatment of IBS in Primary Health Care: Adherence to Guidelines
The purpose of this study is to retrospectively evaluate treatment strategies for IBS used within primary Health care in Örebro Region.
Read the detailed description
The defining features of IBS comprise the presence of recurrent abdominal pain in association with altered bowel habits (diarrhea, constipation or both), as stated in the Rome IV criteria. The spectrum, duration and severity of symptoms can range from inconvenient to incapacitating, and can prevent individuals from participating in everyday activities. Despite the prevalence of IBS, its management remains a challenge for global healthcare systems.
Treatment of IBS comprises, in summary, information to patients, dietary treatment, pharmacological treatment and psychological treatment. Pharmacological treatment includes antidepressants, bulking agents or fiber supplements, rifaximin, linaclotide, eluxadoline, loperamide, antispasmodics, prokinetics and probiotics.
Since the majority of patients with irritable bowel syndrome (IBS) are diagnosed and treated in primary care, the aim of this project is to investigate the adherence of general practitioners (GPs) to recommended therapeutic approaches for IBS.
In this study, data regarding therapeutic approaches will be collected retrospectively over the period of 2013-2019 by using the electronic patient register in Örebro Region. Patients will be identified by ICD-code K.58. The used treatments will be categorized in grade of recommendation as well as in strength of evidence. The efficacy of the used treatments will be evaluated, if possible. Over the counter agents, and lifestyle adjustments will not be evaluated.
The used treatments will be categorized in grade of recommendation (weak and strong) as well as in strength of evidence /very low, low, moderate and high). The eventual use of inappropriate treatments will be recorded as well. The efficacy of the used treatments will be, if possible, evaluated from the patient registers. The standardized and validated questionnaires IBS-Symptom Severity Score and IBS-Quality of Life scores are not routinely used within the primary health care. For this reason, the efficacy of the treatments will be categorized in "no effect, moderate effect and good effect".
Descriptive statistics will be used.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Functional gastrointestinal disorders
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with IBS | Patients diagnosed with IBS within primary care in Region Örebro County 2013-2017, identified by ICD-code K.58. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2013-2017
Secondary outcomes (2)
Efficacy of treatment of IBS
Used treatments of IBS will be categorized in grade of recommendation as well as in strenght of evidence.
Measured: 2013-2017
Use of inappropriate treatments of IBS
The prevalence of inappropriate treatment strategies of IBS within primary care will be recorded.
Measured: 2013-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start29 Nov 2021 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michiel van Nieuwenhoven, M.D. Ph.D., Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144581
- Sponsor's protocol ID
- 277071
- Status last verified
- Nov 2021
- First submitted
- 22 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of IBS in Primary Health Care: Adherence to Guidelines
- ClinicalTrials.gov ID
- NCT05144581
- Acronym / sponsor ID
- 277071
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Functional gastrointestinal disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 29 Nov 2021 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to retrospectively evaluate treatment strategies for IBS used within primary Health care in Örebro Region.
Detailed description
The defining features of IBS comprise the presence of recurrent abdominal pain in association with altered bowel habits (diarrhea, constipation or both), as stated in the Rome IV criteria. The spectrum, duration and severity of symptoms can range from inconvenient to incapacitating, and can prevent individuals from participating in everyday activities. Despite the prevalence of IBS, its management remains a challenge for global healthcare systems.
Treatment of IBS comprises, in summary, information to patients, dietary treatment, pharmacological treatment and psychological treatment. Pharmacological treatment includes antidepressants, bulking agents or fiber supplements, rifaximin, linaclotide, eluxadoline, loperamide, antispasmodics, prokinetics and probiotics.
Since the majority of patients with irritable bowel syndrome (IBS) are diagnosed and treated in primary care, the aim of this project is to investigate the adherence of general practitioners (GPs) to recommended therapeutic approaches for IBS.
In this study, data regarding therapeutic approaches will be collected retrospectively over the period of 2013-2019 by using the electronic patient register in Örebro Region. Patients will be identified by ICD-code K.58. The used treatments will be categorized in grade of recommendation as well as in strength of evidence. The efficacy of the used treatments will be evaluated, if possible. Over the counter agents, and lifestyle adjustments will not be evaluated.
The used treatments will be categorized in grade of recommendation (weak and strong) as well as in strength of evidence /very low, low, moderate and high). The eventual use of inappropriate treatments will be recorded as well. The efficacy of the used treatments will be, if possible, evaluated from the patient registers. The standardized and validated questionnaires IBS-Symptom Severity Score and IBS-Quality of Life scores are not routinely used within the primary health care. For this reason, the efficacy of the treatments will be categorized in "no effect, moderate effect and good effect".
Descriptive statistics will be used.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with IBS | – | –Patients diagnosed with IBS within primary care in Region Örebro County 2013-2017, identified by ICD-code K.58. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with IBS within primary care of Region Örebro County 2013-2017.
Key inclusion criteria (1 listed)
- All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 in Region Örebro County 2013-2017.
Key exclusion criteria (1 listed)
- Patients < 18 years or > 65 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to guidelines of pharmacological treatment of IBS within primary care
Time frame: 2013-2017
The proportion of patients that have received pharmacological treatment according to guidelines for IBS within primary care.
Adherence to guidelines of non-pharmacological treatment of IBS within primary care
Time frame: 2013-2017
The proportion of patients that have received non-pharmacological treatment according to guidelines for IBS within primary care.
2 secondary outcomes
Efficacy of treatment of IBS
Time frame: 2013-2017
Use of inappropriate treatments of IBS
Time frame: 2013-2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michiel van Nieuwenhoven, M.D. Ph.D. principal investigator
Region Örebro County
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Region Örebro County.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jussi Rauma, M.D. (+460702484167, jussi.rauma@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to guidelines of pharmacological treatment of IBS within primary care (time frame: 2013-2017). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.