Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Flupentixol-Melitracen + Lansoprazole

    Drug

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

  • Lansoprazole

    Drug

    Placebo and Lansoprazole for functional dyspepsia.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Patients were treated with Flupentixol-Melitracen (FM) plus lansoprazole for 2 weeksExperimental treatment 1 intervention
Group B: Patients were treated with placebo plus lansoprazole for 2 weeksExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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