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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036761
Enrollment
Unknown
Registered
2020-08-24
Start date
2021-04-01
Completion date
Unknown
Last updated
2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux disease

Interventions

Sponsors

Shanghai Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
metagenome of intestinal flora;Macroproteome of intestinal flora;Electronic gastroscope;Clinical symptom observation table;Quality of Life Rating scale;

Countries

China

Contacts

Public ContactSun yongshun

Shanghai Traditional Chinese Medicine Hospital

13764403043@163.com+86 13764403043

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026