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

NCT ID: NCT06945237

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-24
• Study Completion Date: 2025-10-30

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 and impacts patients' quality of life. Acid suppression remains the primary treatment for GERD. However, numerous clinical studies have shown that 20-30% of patients still exhibit poor response to proton pump inhibitors (PPIs) even after completing a standard course of acid-suppressive therapy. Many studies have demonstrated that the incidence of abnormal psychological conditions, such as anxiety, depression, and obsessive-compulsive disorder, is higher in GERD patients compared to the general population. Current international consensus acknowledges that the application of psychosomatic medicine principles and the use of neuromodulators can effectively alleviate symptoms in patients with gut-brain interaction disorders. Nevertheless, with the growing emphasis on digestive-psychosomatic-holistic medicine in clinical practice and the deepening of research on "gut-brain interactions," recent studies in the field of psycho-gastroenterology have challenged the notion that psychological processes are unique to gut-brain interaction disorders. Instead, these processes may play a universal role in symptom generation across the entire spectrum of GERD. Previous experiments have confirmed that Flupentixol-Melitracen (FM) can improve symptoms in GERD patients with a low incidence of adverse reactions. Therefore, we aim to verify the efficacy and safety of neuromodulators in patients with GERD, reduce healthcare costs, and provide new insights for optimizing treatment strategies for GERD patients in the future.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Patients were treated with Flupentixol-Melitracen (FM) plus lansoprazole for 2 weeks

Group Type: EXPERIMENTAL

Flupentixol-Melitracen + Lansoprazole

Intervention Type: DRUG

Flupentixol-Melitracen and Lansoprazole for the treatment of GERD

Patients were treated with placebo plus lansoprazole for 2 weeks

Group Type: PLACEBO_COMPARATOR

Lansoprazole and placebo

Intervention Type: DRUG

Placebo and Lansoprazole for GERD

Interventions

Flupentixol-Melitracen + Lansoprazole

Flupentixol-Melitracen and Lansoprazole for the treatment of GERD

Intervention Type: DRUG

Lansoprazole and placebo

Placebo and Lansoprazole for GERD

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shengliang Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheng L Chen, doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine，Renji Hospital

Locations

Shanghai Jiaotong university，renji hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

RJYYQKLY-04

Identifier Type: -

Identifier Source: org_study_id