The Effect of PPI in Preventing Gastroesophageal Reflux Disease of Seafarers

NCT04696783 | Unknown Phase 3

• 1 other identifier: ZDWY.XHNK.002
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• Gerd Q score

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

  10 weeks

Secondary Outcomes (2)

• Anxiety and depression scores

  10 weeks

• Intestinal flora analysis

  3 months

Study Arms (2)

Drug Group

EXPERIMENTAL

Esomeprazole Magnesium Enteric-coated Tablets and lifestyle adjustment

Drug: Esomeprazole Magnesium Enteric-coated Tablets; Behavioral: Lifestyle adjustment

non-Drug Group

PLACEBO COMPARATOR

Only lifestyle adjustment

Behavioral: Lifestyle adjustment

Interventions

Esomeprazole Magnesium Enteric-coated Tablets DRUG

Nexium taken once every 2 days plus lifestyle adjustment

Also known as: Nexium

Drug Group

Lifestyle adjustment BEHAVIORAL

Lifestyle adjustment

Drug Group; non-Drug Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hong Shan, MD

  Fifth Affiliated Hospital of Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Liangqing Gao, MM

CONTACT

86+0756+2528841; gaolq3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The chief of the department of gastroenterology

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: July 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share