Gastro Esophageal RefluxREFLUXNCT05689918
Gastroesophageal Reflux Disease in the Dutch Population
An observational study of Gastro Esophageal Reflux, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Screening for esophageal adenocarcinoma (EAC) precursors and treating them may help to decrease mortality of this malignancy. To understand the size of the target population for potential EAC screening, insight in the prevalence of registered and unregistered individuals with gastro-esophageal reflux… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastro Esophageal Reflux
- How many people
- 4,719 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Dec 2022to 7 May 2023
- How long will I take part?
- 1 Day
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Dutch population registry, 'Basisregistratie Personen' (BRP).
Who may be able to join
- Age 18 - 75 years
Who cannot join
- Unable to provide informed consent for any reason;
- Unable to fill out the digital survey for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastroesophageal Reflux Symptoms and Help-seeking Behavior, Medication Use and Esophageal Cancer Awareness: Dutch Population-based Survey
Rationale: Screening for esophageal adenocarcinoma (EAC) precursors and treating them may help to decrease mortality of this malignancy. To understand the size of the target population for potential EAC screening, insight in the prevalence of registered and unregistered individuals with gastro-esophageal reflux disease (GERD) symptoms is needed. Insight in public awareness of EAC will provide additional useful information for public communication strategies.
Objective: The aims of this study are to assess the prevalence of GERD symptoms and related help-seeking behavior, registered and unregistered medication use and awareness of esophageal cancer in the general Dutch population.
Read more
Study design: Cross-sectional population-based survey.
Study population: Dutch citizens aged 18-75 years.
Methods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey.
Main study parameters/endpoints: The outcome variables are presence of current GERD symptoms, number of GERD patients that consulted a doctor, number of GERD patients using prescribed and/or over the counter (OTC) antacids, histamine-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs), and awareness and beliefs about esophageal cancer. The association between socio-demographic background and outcome variables will also be evaluated.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study.
Nonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject.
- Conditions
- Gastro Esophageal Reflux
- Being tested
- No intervention
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of GERD symptoms (heartburn, regurgitation and/or dyspepsia)
The Dutch translation of the validated Reflux Disease Questionnaire will be used to measure this outcome.
Measured: 7 days
Level of awareness of esophageal cancer risk factors and alarm symptoms
The awareness and beliefs about cancer (ABC) measure was adapted for this outcome. The alarm symptom module measures whether participants think dysphagia, change in stool pattern, change in appearance of a mole, weightloss and palpable lesions are alarm symptoms of cancer (yes/no/don't know). The risk factor module measures whether participants think alcohol, smoking, obesity, male sex, GERD symptoms, age>50y, familial esophageal cancer, hot drinks and radiation are risk factors for esophageal cancer on a 4 point scale (strongly disagree - strongly agree).
Measured: Baseline
Secondary outcomes (4)
Number of individuals that sought help for GERD (general practitioner/referral)
Participants with GERD will be asked whether they discussed their symptoms with their GP, whether they have been referred to a gastroenterologist or internist and what their reasons were for seeking help or not seeking help (answer options were based on qualitative research).
Measured: 20 years
Number of individuals with GERD that used antacids, H2RAs and PPI's (prescribed)
Participants will be asked to indicate whether they used prescribed Omeprazol, Pantoprazol, Esomeprazol, Lansoprazol, Rabeprazol, Cimetidine, Famotidine, Nizatidine, Ranitidine, Sucralfate, Misoprostol, Antagel, Gastilox, Maalox, Gaviscon, Regla-pH, Rennie, Magnesiumhydroxide, Iberogast or A. Vogel Boldocynara in the past 6 months.
Measured: 6 months
Number of individuals with GERD that used antacids, H2RAs and PPI's (over-the-counter)
Participants will be asked to indicate whether they used over-the-counter Omeprazol, Pantoprazol, Esomeprazol, Lansoprazol, Rabeprazol, Cimetidine, Famotidine, Nizatidine, Ranitidine, Sucralfate, Misoprostol, Antagel, Gastilox, Maalox, Gaviscon, Regla-pH, Rennie, Magnesiumhydroxide, Iberogast or A. Vogel Boldocynara in the past 6 months.
Measured: 6 months
Beliefs about esophageal cancer
The awareness and beliefs about cancer (ABC) measure was adapted for this outcome. The beliefs module measures whether participants think esophageal cancer can be treated, can be cured, is a death sentence, can benefit from early detection and whether they would wish to know about de diagnosis on a 4 point Likerts scale (strongly disagree - strongly agree).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start7 Dec 2022
- Primary completion7 Mar 2023 (estimated)
- Study completion7 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 4,719 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689918
- Sponsor's protocol ID
- 2022-13720
- Acronym
- REFLUX
- Status last verified
- Nov 2022
- First submitted
- 30 Nov 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Huibertse LJ, Sijben J, Peters Y, Siersema PD. Self-management and help-seeking behavior for gastroesophageal reflux symptoms: A population-based survey. World J Gastroenterol. 2026 Jan 14;32(2):112395. doi: 10.3748/wjg.v32.i2.112395.
PubMed 41551831
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroesophageal Reflux Symptoms and Help-seeking Behavior, Medication Use and Esophageal Cancer Awareness: Dutch Population-based Survey
- ClinicalTrials.gov ID
- NCT05689918
- Acronym / sponsor ID
- REFLUX / 2022-13720
- Conditions
- Gastro Esophageal Reflux
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,719 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 7 Mar 2023 (estimated)
- Study completion
- 7 May 2023 (estimated)
- First posted
- 19 Jan 2023 (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.
Rationale: Screening for esophageal adenocarcinoma (EAC) precursors and treating them may help to decrease mortality of this malignancy. To understand the size of the target population for potential EAC screening, insight in the prevalence of registered and unregistered individuals with gastro-esophageal reflux disease (GERD) symptoms is needed. Insight in public awareness of EAC will provide additional useful information for public communication strategies.
Objective: The aims of this study are to assess the prevalence of GERD symptoms and related help-seeking behavior, registered and unregistered medication use and awareness of esophageal cancer in the general Dutch population.
Study design: Cross-sectional population-based survey.
Study population: Dutch citizens aged 18-75 years.
Methods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey.
Main study parameters/endpoints: The outcome variables are presence of current GERD symptoms, number of GERD patients that consulted a doctor, number of GERD patients using prescribed and/or over the counter (OTC) antacids, histamine-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs), and awareness and beliefs about esophageal cancer. The association between socio-demographic background and outcome variables will also be evaluated.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study.
Nonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Dutch population registry, 'Basisregistratie Personen' (BRP).
Key inclusion criteria (1 listed)
- Age 18 - 75 years
Key exclusion criteria (2 listed)
- Unable to provide informed consent for any reason;
- Unable to fill out the digital survey for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Prevalence of GERD symptoms (heartburn, regurgitation and/or dyspepsia)
Time frame: 7 days
The Dutch translation of the validated Reflux Disease Questionnaire will be used to measure this outcome.
Level of awareness of esophageal cancer risk factors and alarm symptoms
Time frame: Baseline
The awareness and beliefs about cancer (ABC) measure was adapted for this outcome. The alarm symptom module measures whether participants think dysphagia, change in stool pattern, change in appearance of a mole, weightloss and palpable lesions are alarm symptoms of cancer (yes/no/don't know). The risk factor module measures whether participants think alcohol, smoking, obesity, male sex, GERD symptoms, age>50y, familial esophageal cancer, hot drinks and radiation are risk factors for esophageal cancer on a 4 point scale (strongly disagree - strongly agree).
4 secondary outcomes
Number of individuals that sought help for GERD (general practitioner/referral)
Time frame: 20 years
Number of individuals with GERD that used antacids, H2RAs and PPI's (prescribed)
Time frame: 6 months
Number of individuals with GERD that used antacids, H2RAs and PPI's (over-the-counter)
Time frame: 6 months
Beliefs about esophageal cancer
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Derived from this study: PubMed 41551831Huibertse LJ, Sijben J, Peters Y, Siersema PD. Self-management and help-seeking behavior for gastroesophageal reflux symptoms: A population-based survey. World J Gastroenterol. 2026 Jan 14;32(2):112395. doi: 10.3748/wjg.v32.i2.112395.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro Esophageal Reflux, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 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 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of GERD symptoms (heartburn, regurgitation and/or dyspepsia) (time frame: 7 days). 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?
On the ClinicalTrials.gov record for NCT05689918, which also lists 1 linked publication.
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 19 Jan 2023.