Status:
COMPLETED
Efficacy of Gut-Brain Neuromodulators in the Treatment of Gastroesophageal Reflux Disease
Lead Sponsor:
RenJi Hospital
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Gastroesophageal reflux disease (GERD) is a common chronic digestive system disorder with a high prevalence and a notably increasing trend. It imposes significant costs in terms of treatment expenses ...
Eligibility Criteria
Inclusion
- \- Adults aged 18-70 years with gastroesophageal reflux disease (GERD) meeting diagnostic criteria.
Exclusion
- Patients with organic gastrointestinal disorders (e.g., celiac disease, inflammatory bowel disease, history of gastrointestinal malignancies);
- Severe dysfunction of major organs (e.g., class IV cardiac dysfunction, hepatic failure, uremia, respiratory failure) or congenital diseases (e.g., hemophilia, Wilson's disease);
- Hypersensitivity to study medications;
- Patients who are pregnant, lactating, or planning pregnancy;
- Use of monoamine oxidase inhibitors (e.g., linezolid or intravenous methylene blue) within the past 5 weeks;
- Severe psychological symptoms or cognitive impairment (GAD-7 \>15 or PHQ-9 ≥15);
- Circulatory failure, central nervous system depression (e.g., acute alcohol, barbiturate, or opioid intoxication), or coma.
Key Trial Info
Start Date :
April 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2025
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT06945237
Start Date
April 24 2025
End Date
October 30 2025
Last Update
November 18 2025
Active Locations (1)
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1
Shanghai Jiaotong university，renji hospital
Shanghai, Shanghai Municipality, China