Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04696783
Status:
UNKNOWN
Last Update Posted:
2021-01-06
First Post:
2021-01-04
Brief Title:
The Effect of PPI in Preventing Gastroesophageal Reflux Disease of Seafarers
Sponsor:
Fifth Affiliated Hospital Sun Yat-Sen University
Organization:
Fifth Affiliated Hospital Sun Yat-Sen University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 seafarersdisease historypast history demographic data eating habits whether there is high sugar high fat strong tea preferencewhether 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
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 seafarersdisease historypast history demographic data eating habits whether there is high sugar high fat strong tea preferencewhether 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None