Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia

NCT ID: NCT06931223

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2025-09-10

Brief Summary

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.

Conditions

Functioanl Dyspepsia

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 functional dyspepsia.

Patients were treated with placebo plus lansoprazole for 2 weeks

Group Type: EXPERIMENTAL

Lansoprazole

Intervention Type: DRUG

Placebo and Lansoprazole for functional dyspepsia.

Interventions

Flupentixol-Melitracen + Lansoprazole

Flupentixol-Melitracen and Lansoprazole for the treatment of functional dyspepsia.

Intervention Type: DRUG

Lansoprazole

Placebo and Lansoprazole for functional dyspepsia.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shengliang Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

RJYYXHNK-03

Identifier Type: -

Identifier Source: org_study_id