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New drug combo targets brain to soothe stubborn reflux

NCT ID NCT06945237

Disease control Sponsor: RenJi Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether adding a gut-brain neuromodulator (Flupentixol-Melitracen) to standard acid-reducing therapy (Lansoprazole) helps people with gastroesophageal reflux disease (GERD) who still have symptoms on acid suppressants alone. The trial enrolled 164 adults with GERD and measured symptom improvement using a standard questionnaire. The goal is to see if targeting brain-gut connections can provide better relief for this common condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Flupentixol-Melitracen (a combination drug that affects brain chemicals) plus Lansoprazole (a standard acid-reducing drug)
What this could lead to
If successful, this could offer a new treatment option for GERD patients whose symptoms persist despite standard acid-reducing therapy, potentially improving quality of life.
What could go wrong
This is a small, completed trial with 164 participants, so results may not apply to everyone. The drug combination may cause side effects like drowsiness or allergic reactions, and the benefit over standard care may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

164 people

The number who actually took part.

Started

Apr 2025

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Adults aged 18-70 years with gastroesophageal reflux disease (GERD) meeting diagnostic criteria. Exclusion Criteria: * Patients with organic gastrointestinal disorders (e.g., celiac disease, inflammatory bowel disease, history of gastrointestinal malignancies); Severe dysfunction of major organs (e.g., class IV cardiac dysfunction, hepatic failure, uremia, respiratory failure) or congenital diseases (e.g., hemophilia, Wilson's disease); Hypersensitivity to study medications; Patients who are pregnant, lactating, or planning pregnancy; Use of monoamine oxidase inhibitors (e.g., linezolid or intravenous methylene blue) within the past 5 weeks; Severe psychological symptoms or cognitive impairment (GAD-7 \>15 or PHQ-9 ≥15); Circulatory failure, central nervous system depression (e.g., acute alcohol, barbiturate, or opioid intoxication), or coma.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroesophageal reflux disease

Contacts and locations

Locations

  • Shanghai Jiaotong university，renji hospital

    Shanghai, Shanghai Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.