Clinical study on precise diagnosis and treatment of refractory gastroesophageal reflux disease by Traditional Chinese medicine based on intestinal microecological macroomics technology

Phase 1

• Conditions: Gastroesophageal reflux disease

• Registration Number: ITMCTR2000003951
• Lead Sponsor: Shanghai Traditional Chinese Medicine Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The research content 1
1.Inclusion criteria for subjects with refractory gastroesophageal reflux disease
A. Meet the diagnostic criteria of gastroesophageal reflux disease;
B. Eight weeks of standard PPI treatment for failure with gastroesophageal reflux disease prior to this study;
C. Between the ages of 18 and 65, regardless of gender;
D. The patient is informed and signs the informed consent.
2.Inclusion criteria for healthy subjects:
A. Healthy volunteers who had physical examination in our hospital;
B. Between the ages of 18 and 65, regardless of gender;
C. The patient is informed and signs the informed consent.

The research content 2
A. It meets the diagnostic criteria of gastroesophageal reflux disease.
B. Patients who had failed to treat gastroesophageal reflux disease with standard dose PPI for 8 weeks prior to this study.

Exclusion Criteria

The research content 1
A. Patients with one of the following diseases: peptic ulcer, history of gastroesophageal and duodenal surgery, Zo-AIDS syndrome, primary esophageal motional diseases (such as achalasia of cardia, scleroderma, primary esophageal spasm), malignant lesions of upper digestive tract, coronary heart disease, diabetes, drug esophagitis.
B. Pregnant or lactating women,
C. Allergic constitution and psychosis.
D. The patient was a researcher directly involved in this clinical study.
E. Simultaneous use of drugs that may affect the efficacy and safety of drugs.
F. It was considered that there were any circumstances unsuitable for inclusion in the study.

The research content 2
A. Patients with one of the following diseases: peptic ulcer, history of gastroesophageal and duodenal surgery, Zo-AIDS syndrome, primary esophageal motional diseases (such as achalasia of cardia, scleroderma, primary esophageal spasm), malignant lesions of upper digestive tract, coronary heart disease, diabetes, drug esophagitis.
B. Pregnant or lactating women,
C. Allergic constitution and psychosis.
D. The patient was a researcher directly involved in this clinical study.
E. Simultaneous use of drugs that may affect the efficacy and safety of drugs.
F. It was considered that there were any circumstances unsuitable for inclusion in the study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Electronic gastroscope;Macroproteome of intestinal flora;Quality of Life Rating scale;Clinical symptom observation table;metagenome of intestinal flora;