Efficacy of Gut-Brain Neuromodulators in the Treatment of Gastroesophageal Reflux Disease

Launched by RENJI HOSPITAL · Apr 18, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat gastroesophageal reflux disease (GERD), a common condition that causes heartburn and discomfort when stomach acid flows back into the esophagus. While many people with GERD take medications called proton pump inhibitors (PPIs) to reduce acid, some still experience symptoms. Researchers are exploring whether using gut-brain neuromodulators, which are medications that can help with mood and anxiety, might also help relieve GERD symptoms.

To participate in this trial, you need to be an adult between 18 and 70 years old and have a diagnosis of GERD. However, certain health conditions may exclude you, such as severe organ dysfunction or major gastrointestinal disorders. If you join the study, you’ll receive treatment with the neuromodulator Flupentixol-Melitracen (FM) and be monitored for any side effects or improvements in your symptoms. This trial aims to not only find effective treatment options for GERD but also to reduce healthcare costs and improve the overall management of this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Adults aged 18-70 years with gastroesophageal reflux disease (GERD) meeting diagnostic criteria.
• Exclusion Criteria:
• • 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.