Gastroesophageal reflux disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed with GERD and planned to initiate acid-suppressive therapy. 2.Aged 18 years or older; 3.Agreed to participate in the study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Used acid-suppressing agents (e.g., PPIs, H2RAs, PCABs), antacids (e.g., aluminum hydroxide, magnesium aluminum carbonate, alginates), gastrointestinal prokinetic agents (e.g., metoclopramide, domperidone, itopride, mosapride), or gastric mucosal protectants (e.g., bismuth potassium citrate, colloidal bismuth pectin, misoprostol, magnesium aluminum carbonate, sucralfate) in the past 3 months. 2.Have a history of Helicobacter pylori eradication in the past 6 months. 3.Have used laxatives, antibiotics, corticosteroids, metformin, probiotics, or prebiotics in the past 3 months. 4.Have a history of serious gastrointestinal or hepatobiliary diseases or surgeries, such as colorectal cancer, inflammatory bowel disease, colon cancer, liver cancer, etc. 5.Have abnormal bowel movement frequency, such as constipation or diarrhea (less than three bowel movements per week or more than three bowel movements per day). 6.Have severe oral diseases or are undergoing oral treatment, including periodontitis or gingivitis. 7.Have a history of severe, progressive, or uncontrolled heart, liver, kidney, or mental disorders. 8.Have a history of cancer or have undergone cancer treatment, such as chemotherapy, radiation therapy, or immunotherapy. 9.Have a history of drug or alcohol abuse. 10.Pregnant, breastfeeding, or planning to become pregnant; 11.Inability to cooperate, such as an inability to understand the informed consent form or unwillingness to provide personal information; 12.Have mental disorders that hinder cooperation. 13.Have participated in other clinical trials in the past 3 months. 14.Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral Microbiome;Peripheral immune signatures;Omics analysis (transcriptome, proteome, and metabolome);Liver and fidney function;Glucose and lipid metabolism parameter; | — |
Countries
China
Contacts
The Seventh Affiliated Hospital Sun Yat-sen University(Shenzhen)