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The Effect of PPI in Preventing Gastroesophageal Reflux Disease of Seafarers

Primary Purpose

Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Esomeprazole Magnesium Enteric-coated Tablets
Lifestyle adjustment
Sponsored by
Fifth Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Agree to the implementation of this research and sign an informed consent form.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Drug Group

    non-Drug Group

    Arm Description

    Esomeprazole Magnesium Enteric-coated Tablets and lifestyle adjustment

    Only lifestyle adjustment

    Outcomes

    Primary Outcome Measures

    Gerd Q score
    The difference in the proportion of seafarers with a Gerd Q score of 8 or more between the two groups

    Secondary Outcome Measures

    Anxiety and depression scores
    Differences in anxiety and depression scores between the two groups
    Intestinal flora analysis
    Differences in intestinal flora in the two groups

    Full Information

    First Posted
    January 4, 2021
    Last Updated
    January 4, 2021
    Sponsor
    Fifth Affiliated Hospital, Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04696783
    Brief Title
    The Effect of PPI in Preventing Gastroesophageal Reflux Disease of Seafarers
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2021 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    November 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fifth Affiliated Hospital, Sun Yat-Sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux Disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    92 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Drug Group
    Arm Type
    Experimental
    Arm Description
    Esomeprazole Magnesium Enteric-coated Tablets and lifestyle adjustment
    Arm Title
    non-Drug Group
    Arm Type
    Placebo Comparator
    Arm Description
    Only lifestyle adjustment
    Intervention Type
    Drug
    Intervention Name(s)
    Esomeprazole Magnesium Enteric-coated Tablets
    Other Intervention Name(s)
    Nexium
    Intervention Description
    Nexium taken once every 2 days plus lifestyle adjustment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle adjustment
    Intervention Description
    Lifestyle adjustment
    Primary Outcome Measure Information:
    Title
    Gerd Q score
    Description
    The difference in the proportion of seafarers with a Gerd Q score of 8 or more between the two groups
    Time Frame
    10 weeks
    Secondary Outcome Measure Information:
    Title
    Anxiety and depression scores
    Description
    Differences in anxiety and depression scores between the two groups
    Time Frame
    10 weeks
    Title
    Intestinal flora analysis
    Description
    Differences in intestinal flora in the two groups
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Agree to the implementation of this research and sign an informed consent form. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liangqing Gao, MM
    Phone
    86+0756+2528841
    Email
    gaolq3@mail.sysu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hong Shan, MD
    Organizational Affiliation
    Fifth Affiliated Hospital of Sun Yat-Sen University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual participant data would not be available to other researchers in view of the confidentiality requirements of our research.

    Learn more about this trial

    The Effect of PPI in Preventing Gastroesophageal Reflux Disease of Seafarers

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