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NCT Number: NCT06931223

Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Flupentixol-Melitracen + Lansoprazole

Drug

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

Lansoprazole

Drug

Placebo and Lansoprazole for functional dyspepsia.

Primary outcomes

  1. Leuven Postprandial Distress Scale (LPDS) score

    Time frame: Until the end of the study, up to 14 weeks

    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.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2025
Registry last updated
Apr 17, 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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