Functioanl DyspepsiaNCT06931223
Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia
A study testing Flupentixol-Melitracen + Lansoprazole and Lansoprazole in people with Functioanl Dyspepsia, run by RenJi Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functioanl Dyspepsia
- What is being tested?
- Flupentixol-Melitracen + Lansoprazole and Lansoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Efficacy of Gut-rain Neuromodulators in the Treatment of Functional Dyspepsia: a Randomized Controlled Study
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
- Being tested
- Flupentixol-Melitracen + Lansoprazole, Lansoprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flupentixol-Melitracen + LansoprazoleDrug
Flupentixol-Melitracen and Lansoprazole for the treatment of functional dyspepsia.
LansoprazoleDrug
Placebo and Lansoprazole for functional dyspepsia.
| Study group | Role | What they receive |
|---|---|---|
| Patients were treated with Flupentixol-Melitracen (FM) plus lansoprazole for 2 weeks | Experimental | Not described Receives: Drug: Flupentixol-Melitracen + Lansoprazole |
| Patients were treated with placebo plus lansoprazole for 2 weeks | Experimental | Not described Receives: Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until the end of the study, up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start10 Apr 2025 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functioanl DyspepsiaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengliang Chen, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931223
- Sponsor's protocol ID
- RJYYXHNK-03
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gut-rain Neuromodulators in the Treatment of Functional Dyspepsia: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06931223
- Acronym / sponsor ID
- RJYYXHNK-03
- Conditions
- Functioanl Dyspepsia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flupentixol-Melitracen + LansoprazoleFlupentixol-Melitracen and Lansoprazole for the treatment of functional dyspepsia. | Drug | Patients were treated with Flupentixol-Melitracen (FM) plus lansoprazole for 2 weeks |
| LansoprazolePlacebo and Lansoprazole for functional dyspepsia. | Drug | Patients were treated with placebo plus lansoprazole for 2 weeks |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
Related trials for Functioanl Dyspepsia
Recruiting
Vonoprazan Alone vs With Itopride for Functional Dyspepsia: The VIVA Trial
Functioanl Dyspepsia
Not yet recruitingPhase 4
Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia.
Dyspepsia, Functioanl Dyspepsia
Not yet recruitingPhase 4
Comparing Acotiamide and Itopride for the Management of Indigestion
Functioanl Dyspepsia, Post Prandial Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Flupentixol-Melitracen + Lansoprazole and Lansoprazole in people with Functioanl Dyspepsia, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leuven Postprandial Distress Scale (LPDS) score (time frame: Until the end of the study, up to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.