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Mind over belly: talk therapy may soothe stomach pain

NCT ID NCT07577089

Symptom relief Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether adding Cognitive Behavioral Therapy (CBT) to standard medical care can reduce stomach symptoms in adults with functional dyspepsia, a condition causing pain or discomfort after eating. About 90 adults aged 18-65 will be randomly assigned to receive either standard treatment alone or standard treatment plus CBT. Participants will fill out questionnaires and provide blood, saliva, and stool samples over 12 months to track changes in symptoms and quality of life.

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

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

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 65 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: * Age 18-65 years * Diagnosis of Functional Dyspepsia according to Rome IV criteria * Classification as Epigastric Pain Syndrome (EPS) or Postprandial Distress Syndrome (PDS) * Active symptoms within the last month * Willingness to participate in Cognitive Behavioral Therapy and provide biological samples for research * Ability to provide written informed consent Exclusion Criteria: * Presence of structural gastrointestinal disease (e.g., peptic ulcer, malignancy) * History of major abdominal surgery affecting the stomach or small intestine * Severe psychiatric disorders (e.g., psychosis, bipolar disorder) interfering with participation * Current participation in other interventional clinical trials * Use of medications that may confound study outcomes (e.g., chronic corticosteroids, immunosuppressants) * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

dyspepsia functional gastric disease Inflammation

As listed by the trial registrant

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

Epigastric pain syndrome Functional dyspepsia Postprandial distress syndrome

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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