Gastroesophageal Reflux DiseasePhase 3NCT04696783
The Effect of PPI in Preventing Gastroesophageal Reflux Disease of Seafarers
A Phase 3 study testing Esomeprazole Magnesium Enteric-coated Tablets and Lifestyle adjustment in people with Gastroesophageal Reflux Disease, run by Fifth Affiliated Hospital, Sun Yat-Sen University.
Trial summary
In view of the high incidence of GERD among seafarers and its continuing impact on the life quality of seafarers, it is necessary to use preventive treatment. At the same time, because both mental and psychological factors and changes in intestinal flora may play a certain role in the development and treatment of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Esomeprazole Magnesium Enteric-coated Tablets and Lifestyle adjustment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Nov 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agree to the implementation of this research and sign an informed consent form.
Who cannot join
- PPI drugs were previously used to treat acid-related diseases or conditions (including peptic ulcer, non-variceal upper gastrointestinal hemorrhage, gastroesophageal reflux disease, Zollinger-Ellison syndrome, and functional dyspepsia, eradication of Helicobacter pylori) 2 weeks before enrollment).
- Those having a history of stomach surgery.
- Those who have alarm symptoms (recent weight loss for unknown reasons, such as 5% or more of the original weight loss in the first half of the year; Progressive dysphagia, anemia, hematemesis, melena, hematochezia)or physical examination shows abnormalities such as abdominal rebound pain, masses, etc.).
- Pregnant or lactating women.
- Serious diseases and complications that may interfere with the research, such as heart, liver, kidney, lung, peripheral or autonomic nervous diseases, diabetes, etc.
- Allergic to PPI drugs.
- Having a history of drug abuse.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Research on the Effect of PPI in Preventing Gastroesophageal Reflux Disease of Seafarers and Its Influence on Intestinal Flora and Mental State
In view of the high incidence of GERD among seafarers and its continuing impact on the life quality of seafarers, it is necessary to use preventive treatment. At the same time, because both mental and psychological factors and changes in intestinal flora may play a certain role in the development and treatment of GERD, this project intends to take the seafarers involved in this scientific expedition as the participants to explore the effect of PPI discontinuous therapy in preventing gastroesophageal reflux disease of seafarers, a special occupational group and the changes in the mental and psychological status and intestinal flora of this group of people after PPI therapy.
Read the detailed description
Gastroesophageal reflux disease (GERD) is one of the common digestive system diseases. However, at present, there are only sporadic reports on the diagnosis and treatment of seafarers' gastroesophageal reflux disease in the world, and there is a lack of systematic research and standardized diagnosis and treatment, especially in the prevention of GERD.
Seafarers work and live in a special marine environment for a long time and belong to a group of specific occupations. Studies have shown that the incidence of gastroesophageal reflux disease can be as high as 27% after 8 weeks of sailing, which is significantly higher than the prevalence of GERD worldwide. When single or multiple factors such as mental illness, high-fat diet, and changes in intestinal flora are combined, they have a significant additive effect and jointly promote the occurrence of GERD. In addition, the main treatment for gastroesophageal reflux disease is proton pump inhibitor (PPI), but long-term use of PPI may cause many adverse reactions. Because PPI can significantly increase the potential of hydrogen (PH) value in the stomach, long-term use of PPI to treat gastroesophageal reflux disease may cause changes in the microbiota colonized in the small and large intestines, and cause some symptoms related to intestinal flora disorders.
GERD is a chronic and recurrent disease that seriously affects the life quality. In addition to symptoms, gastroscopy and 24-hour esophageal pH testing are the main basis for diagnosis. However, during the voyage, the above procedures could not be carried out in time, resulting in delayed diagnosis and aggravated illness. Moreover, gastroscopy is generally suitable for people with alarm symptoms and it is not feasible for all people to receive gastroscopy,. In addition, although the 24-hour pH test is the gold standard for gastroesophageal reflux disease, it is generally used for people with negative gastroscopy and poor response to conventional treatment given the fact that it is invasive and there are not many hospitals that carry out the test. Because gastroesophageal reflux disease can be diagnosed clinically, in recent years, the gastroesophageal reflux disease questionnaire (Gerd Q) has been used for the preliminary clinical diagnosis of GERD. Studies have shown that with Gerd Q, family physicians and gastroenterologists have moderate or similar accuracy in the diagnosis of GERD. Many studies have shown that it has good authenticity and reliability. Therefore, this study did not use gastroscopy and 24-hour esophageal pH testing in the research steps, and the more practical Gerd Q scale was used for the diagnosis and evaluation of seafarers' GERD.
The first stage: record all seafarers'disease history/past history, demographic data, eating habits (whether there is high sugar, high fat, strong tea preference;whether drinking or smoking), vital signs, physical examination results, complete blood count, liver function, blood biochemistry, Gerd Q scale test and anxiety and depression scale evaluation, collect all seafarers' fecal samples before going to sea.
The second stage: After successful enrollment and intervention, the two groups of seafarers will be scored with Gerd Q and anxiety and depression scale every week, and fecal specimens of the two groups of seafarers will be collected for intestinal flora analysis. During the voyage, fecal specimens were collected in 5ml non-enzymatic drying tubes and stored in the -80℃ refrigerator on board. The entire intervention process continued until the end of the voyage.
The third stage: The efficacy evaluation stage.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Esomeprazole Magnesium Enteric-coated Tablets, Lifestyle adjustment
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole Magnesium Enteric-coated TabletsDrug
Also called Nexium
Nexium taken once every 2 days plus lifestyle adjustment
Lifestyle adjustmentBehavioural
Lifestyle adjustment
| Study group | Role | What they receive |
|---|---|---|
| Drug Group | Experimental | Esomeprazole Magnesium Enteric-coated Tablets and lifestyle adjustment Receives: Drug: Esomeprazole Magnesium Enteric-coated Tablets; Behavioral: Lifestyle adjustment |
| non-Drug Group | Placebo comparator | Only lifestyle adjustment Receives: Behavioral: Lifestyle adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gerd Q score
The difference in the proportion of seafarers with a Gerd Q score of 8 or more between the two groups
Measured: 10 weeks
Secondary outcomes (2)
Anxiety and depression scores
Differences in anxiety and depression scores between the two groups
Measured: 10 weeks
Intestinal flora analysis
Differences in intestinal flora in the two groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study startJul 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng Li, Fifth Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Hong Shan, MD, Study director, Fifth Affiliated Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696783
- Sponsor's protocol ID
- ZDWY.XHNK.002
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data would not be available to other researchers in view of the confidentiality requirements of our research.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on the Effect of PPI in Preventing Gastroesophageal Reflux Disease of Seafarers and Its Influence on Intestinal Flora and Mental State
- ClinicalTrials.gov ID
- NCT04696783
- Acronym / sponsor ID
- ZDWY.XHNK.002
- Conditions
- Gastroesophageal Reflux Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 6 Jan 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.
In view of the high incidence of GERD among seafarers and its continuing impact on the life quality of seafarers, it is necessary to use preventive treatment. At the same time, because both mental and psychological factors and changes in intestinal flora may play a certain role in the development and treatment of GERD, this project intends to take the seafarers involved in this scientific expedition as the participants to explore the effect of PPI discontinuous therapy in preventing gastroesophageal reflux disease of seafarers, a special occupational group and the changes in the mental and psychological status and intestinal flora of this group of people after PPI therapy.
Detailed description
Gastroesophageal reflux disease (GERD) is one of the common digestive system diseases. However, at present, there are only sporadic reports on the diagnosis and treatment of seafarers' gastroesophageal reflux disease in the world, and there is a lack of systematic research and standardized diagnosis and treatment, especially in the prevention of GERD.
Seafarers work and live in a special marine environment for a long time and belong to a group of specific occupations. Studies have shown that the incidence of gastroesophageal reflux disease can be as high as 27% after 8 weeks of sailing, which is significantly higher than the prevalence of GERD worldwide. When single or multiple factors such as mental illness, high-fat diet, and changes in intestinal flora are combined, they have a significant additive effect and jointly promote the occurrence of GERD. In addition, the main treatment for gastroesophageal reflux disease is proton pump inhibitor (PPI), but long-term use of PPI may cause many adverse reactions. Because PPI can significantly increase the potential of hydrogen (PH) value in the stomach, long-term use of PPI to treat gastroesophageal reflux disease may cause changes in the microbiota colonized in the small and large intestines, and cause some symptoms related to intestinal flora disorders.
GERD is a chronic and recurrent disease that seriously affects the life quality. In addition to symptoms, gastroscopy and 24-hour esophageal pH testing are the main basis for diagnosis. However, during the voyage, the above procedures could not be carried out in time, resulting in delayed diagnosis and aggravated illness. Moreover, gastroscopy is generally suitable for people with alarm symptoms and it is not feasible for all people to receive gastroscopy,. In addition, although the 24-hour pH test is the gold standard for gastroesophageal reflux disease, it is generally used for people with negative gastroscopy and poor response to conventional treatment given the fact that it is invasive and there are not many hospitals that carry out the test. Because gastroesophageal reflux disease can be diagnosed clinically, in recent years, the gastroesophageal reflux disease questionnaire (Gerd Q) has been used for the preliminary clinical diagnosis of GERD. Studies have shown that with Gerd Q, family physicians and gastroenterologists have moderate or similar accuracy in the diagnosis of GERD. Many studies have shown that it has good authenticity and reliability. Therefore, this study did not use gastroscopy and 24-hour esophageal pH testing in the research steps, and the more practical Gerd Q scale was used for the diagnosis and evaluation of seafarers' GERD.
The first stage: record all seafarers'disease history/past history, demographic data, eating habits (whether there is high sugar, high fat, strong tea preference;whether drinking or smoking), vital signs, physical examination results, complete blood count, liver function, blood biochemistry, Gerd Q scale test and anxiety and depression scale evaluation, collect all seafarers' fecal samples before going to sea.
The second stage: After successful enrollment and intervention, the two groups of seafarers will be scored with Gerd Q and anxiety and depression scale every week, and fecal specimens of the two groups of seafarers will be collected for intestinal flora analysis. During the voyage, fecal specimens were collected in 5ml non-enzymatic drying tubes and stored in the -80℃ refrigerator on board. The entire intervention process continued until the end of the voyage.
The third stage: The efficacy evaluation stage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Group | Experimental | Drug: Esomeprazole Magnesium Enteric-coated Tablets, Behavioral: Lifestyle adjustmentEsomeprazole Magnesium Enteric-coated Tablets and lifestyle adjustment |
| non-Drug Group | Placebo comparator | Behavioral: Lifestyle adjustmentOnly lifestyle adjustment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Agree to the implementation of this research and sign an informed consent form.
Key exclusion criteria (7 listed)
- PPI drugs were previously used to treat acid-related diseases or conditions (including peptic ulcer, non-variceal upper gastrointestinal hemorrhage, gastroesophageal reflux disease, Zollinger-Ellison syndrome, and functional dyspepsia, eradication of Helicobacter pylori) 2 weeks before enrollment).
- Those having a history of stomach surgery.
- Those who have alarm symptoms (recent weight loss for unknown reasons, such as 5% or more of the original weight loss in the first half of the year; Progressive dysphagia, anemia, hematemesis, melena, hematochezia)or physical examination shows abnormalities such as abdominal rebound pain, masses, etc.).
- Pregnant or lactating women.
- Serious diseases and complications that may interfere with the research, such as heart, liver, kidney, lung, peripheral or autonomic nervous diseases, diabetes, etc.
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 |
|---|---|---|
| Esomeprazole Magnesium Enteric-coated TabletsAlso: NexiumNexium taken once every 2 days plus lifestyle adjustment | Drug | Drug Group |
| Lifestyle adjustmentLifestyle adjustment | Behavioural | Drug Group, non-Drug Group |
Primary outcome
Gerd Q score
Time frame: 10 weeks
The difference in the proportion of seafarers with a Gerd Q score of 8 or more between the two groups
2 secondary outcomes
Anxiety and depression scores
Time frame: 10 weeks
Intestinal flora analysis
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: No. Individual participant data would not be available to other researchers in view of the confidentiality requirements of our research.
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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.
Hong Shan, MD study director
Fifth Affiliated Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole Magnesium Enteric-coated Tablets and Lifestyle adjustment in people with Gastroesophageal Reflux Disease, run by Fifth Affiliated Hospital, Sun Yat-Sen University.
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 7 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 6 Jan 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Liangqing Gao, MM (86+0756+2528841, gaolq3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gerd Q score (time frame: 10 weeks). 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 6 Jan 2021.