Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia

NCT06931223 | Not Yet Recruiting

• 1 other identifier: RJYYXHNK-03
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

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

EXPERIMENTAL

Drug: Lansoprazole

Interventions

Flupentixol-Melitracen + Lansoprazole DRUG

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

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

Lansoprazole DRUG

Placebo and Lansoprazole for functional dyspepsia.

Patients were treated with placebo plus lansoprazole for 2 weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Interventions

flupentixol, melitracen drug combination; Lansoprazole

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 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: March 31, 2025
• First Posted: April 17, 2025
• Study Start: April 10, 2025
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-03