Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04696783 |
| Other study ID # |
ZDWY.XHNK.002 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
July 2021 |
| Est. completion date |
November 2021 |
Study information
| Verified date |
January 2021 |
| Source |
Fifth Affiliated Hospital, Sun Yat-Sen University |
| Contact |
Liangqing Gao, MM |
| Phone |
86+0756+2528841 |
| Email |
gaolq3[@]mail.sysu.edu.cn |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
