NCT06931223

Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Flupentixol-Melitracen + Lansoprazole	Flupentixol-Melitracen and Lansoprazole for the treatment of functional dyspepsia.
DRUG	Lansoprazole	Placebo and Lansoprazole for functional dyspepsia.

Timeline

• Start date: 2025-04-10
• Primary completion: 2025-09-10
• Completion: 2025-09-10
• First posted: 2025-04-17
• Last updated: 2025-04-17