Gastro -Oesophagal RefluxNCT07164274
Prevalence of GERD, Its Effect on HRQL and Psychological Disturbance, and the Effect of Eating Behaviors on GERD Prevalence
An observational study of Gastro -Oesophagal Reflux and Eating Behavior Disorders, run by Zagazig University at 1 site in Egypt.
Trial summary
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease. It is a chronic condition that is characterized by the regurgitation of stomach contents into the esophagus and is associated with heartburn. The occurrence of these symptoms for at least two weeks increases the likelihood of having GERD. Read more about this study
- Who is it for?
- Ages 18 to 27 years
- Conditions the study is for
- Gastro -Oesophagal Reflux, Eating Behavior Disorders
- What is being tested?
- Questionnaire
- How many people
- 3,773 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2025to 30 Dec 2025
- 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 27 years
- All sexes
- Adult
Study population: Medical students and interns in the Middle East countries
Who may be able to join
- Medical students and interns studying medicine in the Middle East countries
- Have access to online platforms
Who cannot join
- Students or interns who refused to participate
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Zagazig University Faculty of Medicine and Affiliated Hospital
Zagazig
About this study
Official title: Prevalence of Gastroesophageal Reflux Disease, Its Association With Eating Behavior and Psychological Disturbance, and Its Impact On Quality Of Life, Among Medical Students In The MENA Region, A Multinational Cross-Sectional Study
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease. It is a chronic condition that is characterized by the regurgitation of stomach contents into the esophagus and is associated with heartburn. The occurrence of these symptoms for at least two weeks increases the likelihood of having GERD. Other GERD symptoms include chest pain, nausea, dysphagia, burping, water brash, and vomiting. All these symptoms negatively affect the patients' quality of life. The pathophysiology of GERD is multifactorial. Several factors have been suggested to cause GERD, including a hypotensive lower esophageal sphincter (LOS) and a defect in the gastric sling/clasp muscle fiber component.
The global prevalence of GERD is about 13.98% with variation among different countries and ethnic groups. In East Asia, it ranges from 2.5% to 7.5%, 8.5 to 25.9% in Europe, 18.1% to 27.8% in South and North America, and about 11.6% in Australia. In the Middle East, it ranges from 8.7% to 33.1%.
Read more
Several risk factors have been identified that increase the likelihood of having GERD. Obesity was found to be one of the risk factors that increases GERD. Also, dietary habits such as spicy food, coffee drinks, or administering NSAIDs increase the prevalence of having GERD.
On the other hand, psychological factors also play an important role in GERD severity. Both stress and anxiety are linked to an increase in GERD. A previous study showed that stress can increase heartburn symptoms in patients with heartburn and also increase in anxiety level was associated with an increase in esophageal reflux. Finally, depression was found to be associated with GERD, which can be explained by a change in the eating behavior in depressed patients.
Rationale Medical students suffer from a study burden, which increases their level of anxiety and stress. They also have a higher likelihood of having trouble with eating behavior or having a lot of coffee daily. This increases their likelihood of having GERD. In the Middle East, fewer studies have assessed the effect of GERD. A recent cross-sectional study assessed the prevalence of GERD among medical students in Egypt. They found a prevalence of 17.1%. They found an association between increasing stress levels and increasing GERD severity. Also, smoking was a significant risk factor for GERD symptoms. Another cross-sectional study among medical students in 21 universities in Egypt. They reported a prevalence of 28.4%. Again, they found that an increasing level of stress and anxiety was associated with increasing GERD severity. Finally, Two cross-sectional studies were conducted in Saudi Arabia. They reported a prevalence of 23.8% and 23.1% respectively. To our knowledge, no study has assessed the GERD and its related quality of life among medical students in Middle East and linked their findings with eating behaviour
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
An online questionnaire that will be shared via online platforms for medical students and interns in the Middle East countries to fill.
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD prevalence
The GERDQ questionnaire will be used. It is composed of 6 Likert scale questions that ask about GERD symptoms such as heartburn, nausea, and regurgitation. Each question has 4 answers scored from 0 to 3, making a rank from 0 to 18. If the participant scores 8 or more, this diagnosis is GERD. Furthermore, the severity can be assessed. A score of 0-2 makes 0 % of having GERD, 3-7 makes a 50% likelihood of having GERD, 8-10 makes a 79% and 11-18 makes a 89% of having GERD. This questionnaire has a sensitivity being 65% and a specificity being 71% to diagnose GERD
Measured: through study completion, an average of 6 months
GERD_HRQL
The GERD-HRQL was used. This is a 16 Likert scale questionnaire that asks about the effect of GERD symptoms on the quality of life. The first 15 questions had 6 answers, ranging from no symptoms to Symptoms that are incapacitating - unable to do daily activities. This score ranges from 0 to 5. The sixteenth question asks about the present condition. The quality of life is calculated via the first 15 questions (scores from 0 to 75), with higher scores indicating lower quality of life.
Measured: through study completion, an average of 6 months
Secondary outcomes (2)
Eating behavior disorder
The Dutch Eating Behavior Questionnaire (DEBQ) was used. This is a 33 Likert scale questionnaire that assesses the eating behavior in three items (retained eating, emotional eating, and External eating). Each question is composed of 5 answers (from never to very often) and scores range from 1 to 5
Measured: through study completion, an average of 6 months
Psychological disturbance
the DASS-21 was uses questionnaire. This is composed of 21 Likert scale questions, each had 4 answers scored from 0 to 3. The scale is divided into 3 sections to assess depression, stress, and anxiety. The cumulative score for each part will be multiplied by two for interpretation of the severity of each section.
- For the Depression score, 0-9 indicates a normal person, 10-13 indicates mild symptoms, 14-20 indicates moderate, 21-27 indicates severe symptoms, and 28+ indicates extremely severe symptoms.
- For anxiety scores, 0-7 indicates a normal person, and (8-9), (10-14), (15-19), and 20+ indicate mild, moderate, severe, and extremely severe levels of anxiety.
- For stress scores, 0-14 indicates a normal person. A score of (15-18), (19-25), 26-33), and 34+ indicate a mild, moderate, severe, and extremely severe levels of stress.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start5 Aug 2025
- Primary completion30 Nov 2025
- Study completion30 Dec 2025
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 -Oesophagal RefluxStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdelmonam Mamdouh Abdelmonam Mohamed Ahmed Hagag, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164274
- Sponsor's protocol ID
- ZU-IRB# 1580/5-Aug-2025
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
Publications
Jones R, Junghard O, Dent J, Vakil N, Halling K, Wernersson B, Lind T. Development of the GerdQ, a tool for the diagnosis and management of gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1030-8. doi: 10.1111/j.1365-2036.2009.04142.x. Epub 2009 Sep 8.
PubMed 19737151
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Gastroesophageal Reflux Disease, Its Association With Eating Behavior and Psychological Disturbance, and Its Impact On Quality Of Life, Among Medical Students In The MENA Region, A Multinational Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07164274
- Acronym / sponsor ID
- ZU-IRB# 1580/5-Aug-2025
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,773 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 10 Sep 2025 (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.
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease. It is a chronic condition that is characterized by the regurgitation of stomach contents into the esophagus and is associated with heartburn. The occurrence of these symptoms for at least two weeks increases the likelihood of having GERD. Other GERD symptoms include chest pain, nausea, dysphagia, burping, water brash, and vomiting. All these symptoms negatively affect the patients' quality of life. The pathophysiology of GERD is multifactorial. Several factors have been suggested to cause GERD, including a hypotensive lower esophageal sphincter (LOS) and a defect in the gastric sling/clasp muscle fiber component.
The global prevalence of GERD is about 13.98% with variation among different countries and ethnic groups. In East Asia, it ranges from 2.5% to 7.5%, 8.5 to 25.9% in Europe, 18.1% to 27.8% in South and North America, and about 11.6% in Australia. In the Middle East, it ranges from 8.7% to 33.1%.
Several risk factors have been identified that increase the likelihood of having GERD. Obesity was found to be one of the risk factors that increases GERD. Also, dietary habits such as spicy food, coffee drinks, or administering NSAIDs increase the prevalence of having GERD.
On the other hand, psychological factors also play an important role in GERD severity. Both stress and anxiety are linked to an increase in GERD. A previous study showed that stress can increase heartburn symptoms in patients with heartburn and also increase in anxiety level was associated with an increase in esophageal reflux. Finally, depression was found to be associated with GERD, which can be explained by a change in the eating behavior in depressed patients.
Rationale Medical students suffer from a study burden, which increases their level of anxiety and stress. They also have a higher likelihood of having trouble with eating behavior or having a lot of coffee daily. This increases their likelihood of having GERD. In the Middle East, fewer studies have assessed the effect of GERD. A recent cross-sectional study assessed the prevalence of GERD among medical students in Egypt. They found a prevalence of 17.1%. They found an association between increasing stress levels and increasing GERD severity. Also, smoking was a significant risk factor for GERD symptoms. Another cross-sectional study among medical students in 21 universities in Egypt. They reported a prevalence of 28.4%. Again, they found that an increasing level of stress and anxiety was associated with increasing GERD severity. Finally, Two cross-sectional studies were conducted in Saudi Arabia. They reported a prevalence of 23.8% and 23.1% respectively. To our knowledge, no study has assessed the GERD and its related quality of life among medical students in Middle East and linked their findings with eating behaviour
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Age groups
- Adult
- Study population
- Medical students and interns in the Middle East countries
Key inclusion criteria (2 listed)
- Medical students and interns studying medicine in the Middle East countries
- Have access to online platforms
Key exclusion criteria (1 listed)
- Students or interns who refused to participate
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 |
|---|---|---|
| QuestionnaireAn online questionnaire that will be shared via online platforms for medical students and interns in the Middle East countries to fill. | Other | – |
Primary outcome
GERD prevalence
Time frame: through study completion, an average of 6 months
The GERDQ questionnaire will be used. It is composed of 6 Likert scale questions that ask about GERD symptoms such as heartburn, nausea, and regurgitation. Each question has 4 answers scored from 0 to 3, making a rank from 0 to 18. If the participant scores 8 or more, this diagnosis is GERD. Furthermore, the severity can be assessed. A score of 0-2 makes 0 % of having GERD, 3-7 makes a 50% likelihood of having GERD, 8-10 makes a 79% and 11-18 makes a 89% of having GERD. This questionnaire has a sensitivity being 65% and a specificity being 71% to diagnose GERD
GERD_HRQL
Time frame: through study completion, an average of 6 months
The GERD-HRQL was used. This is a 16 Likert scale questionnaire that asks about the effect of GERD symptoms on the quality of life. The first 15 questions had 6 answers, ranging from no symptoms to Symptoms that are incapacitating - unable to do daily activities. This score ranges from 0 to 5. The sixteenth question asks about the present condition. The quality of life is calculated via the first 15 questions (scores from 0 to 75), with higher scores indicating lower quality of life.
2 secondary outcomes
Eating behavior disorder
Time frame: through study completion, an average of 6 months
Psychological disturbance
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Results publication: PubMed 19737151Jones R, Junghard O, Dent J, Vakil N, Halling K, Wernersson B, Lind T. Development of the GerdQ, a tool for the diagnosis and management of gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1030-8. doi: 10.1111/j.1365-2036.2009.04142.x. Epub 2009 Sep 8.
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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 -Oesophagal Reflux and Eating Behavior Disorders, run by Zagazig University at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 1 Sep 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
GERD prevalence (time frame: through study completion, an average of 6 months). 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 NCT07164274, 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 1 Sep 2026.