Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia

Efficacy of Gut-rain Neuromodulators in the Treatment of Functional Dyspepsia: a Randomized Controlled Study

The use of Neuromodulators is now recognized by international consensus as effective in improving Disorders of Gut-Brain Interaction (DGBIs). However, the digestive mind-body concept of therapeutic drugs is still in the experience-based treatment stage, and there is a lack of clinical studies in the field of DGBIs. Although numerous studies have been conducted to confirm the safety of Neuromodulators for the treatment of DGBIs, the current functional dyspepsia (FD) treatment is still awaiting further explorations and accumulations. In addition, neuromodulators, like Flupentixol-Melitracen (FM), are often used as a second-line treatment option for FD after the failure of acid-suppressive therapy with proton pump inhibitors, etc. However, the efficacy of conventional drugs for FD is mediocre, which often leads to recurrent and prolonged symptoms, seriously affecting patients' confidence in treatment and their quality of life, and the repeated visits to the clinic also create a huge economic burden for the society. Therefore, we conducted a clinical trial to verify whether FM can be used as the first-line therapy to improve the efficacy of FD patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Functioanl Dyspepsia
• Intervention / Treatment: Drug: Flupentixol-Melitracen + Lansoprazole; Drug: Lansoprazole

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. adult patients with primary FD who meet the diagnostic criteria for Roman IV;
2. able to complete the questionnaire, trial evaluation and sign the written informed consent.

Exclusion Criteria:

1. organic gastrointestinal diseases by gastroenteroscopy within 6 months;
2. severe insufficiency of heart, liver, kidney, lung and other important organs and with congenital diseases;
3. allergic to the drugs used in this study
4. being pregnant, lactating or planning to become pregnant;
5. are taking or have taken monoamine oxidase inhibitors within the past 5 weeks;
6. have a known risk of narrow angle glaucoma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients were treated with Flupentixol-Melitracen (FM) plus lansoprazole for 2 weeks	Drug: Flupentixol-Melitracen + Lansoprazole; Flupentixol-Melitracen and Lansoprazole for the treatment of functional dyspepsia.
Experimental: Patients were treated with placebo plus lansoprazole for 2 weeks	Drug: Lansoprazole; Placebo and Lansoprazole for functional dyspepsia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leuven Postprandial Distress Scale (LPDS) score	The LPDS questionnaire contains 8 symptoms, namely early satiation, postprandial fullness, upper abdominal bloating, epigastric pain, epigastric burning, nausea, belching, and heartburn. Each symptom was rated on a severity scale of 0-4. The mean of the early satiation, postprandial fullness, and upper abdominal bloating scores was calculated as the postprandial distress syndrome score, and the mean of the epigastric pain, epigastric burning scores was calculated as the epigastric pain syndrome. Changes in LPDS score during the treatment period were assessed.	Until the end of the study, up to 14 weeks

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2025
• Primary Completion (Estimated): September 10, 2025
• Study Completion (Estimated): September 10, 2025

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Central Nervous System Depressants; Neurotransmitter Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Antipsychotic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dopamine Antagonists; Dexlansoprazole; Lansoprazole; Flupenthixol; Flupenthixol decanoate
• Other Study ID Numbers: RJYYXHNK-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No