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Completed

NCT Number: NCT06945237

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiaotong university,renji hospital

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flupentixol-Melitracen + Lansoprazole

Drug

Flupentixol-Melitracen and Lansoprazole for the treatment of GERD

Lansoprazole and placebo

Drug

Placebo and Lansoprazole for GERD

Primary outcomes

  1. GERD questionnaire (GerdQ)

    Time frame: Until the end of the study, up to 12 weeks

    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).

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

A Randomized Controlled Study on the Efficacy and Safety of Gut-Brain Neuromodulators in Patients With Gastroesophageal Reflux Disease

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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