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

NCT06945237 | Completed

• 1 other identifier: RJYYQKLY-04
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• GERD questionnaire (GerdQ)

  The GerdQ Scale is a validated tool for assessing gastroesophageal reflux disease (GERD). It includes 6 items evaluating symptom frequency (heartburn, regurgitation), extra-esophageal manifestations, and quality of life impact (e.g., sleep disturbance, medication use) over the past week. Scores range 0-18; ≥8 suggests high GERD likelihood, guiding stepwise treatment (lifestyle changes or PPIs).

  Until the end of the study, up to 12 weeks

Study Arms (2)

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

EXPERIMENTAL

Drug: Flupentixol-Melitracen + Lansoprazole

Patients were treated with placebo plus lansoprazole for 2 weeks

PLACEBO COMPARATOR

Drug: Lansoprazole and placebo

Interventions

Flupentixol-Melitracen + Lansoprazole DRUG

Flupentixol-Melitracen and Lansoprazole for the treatment of GERD

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

Lansoprazole and placebo DRUG

Placebo and Lansoprazole for GERD

Patients were treated with placebo plus lansoprazole for 2 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adults aged 18-70 years with gastroesophageal reflux disease (GERD) meeting diagnostic criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Shanghai Jiaotong university，renji hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

flupentixol, melitracen drug combination; Lansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sheng L Chen, doctor

  Shanghai Jiao Tong University School of Medicine，Renji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: April 24, 2025
• Primary Completion: August 1, 2025
• Study Completion: October 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-04

Locations

CN (1)