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Can therapy help you eat again when your stomach hurts?

NCT ID NCT05587127

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This study tests a type of talking therapy called exposure-based cognitive behavioral therapy (CBT) for adults who have both functional dyspepsia (a stomach condition causing pain and fullness) and avoidant/restrictive food intake disorder (ARFID), leading to weight loss. Fifty participants will receive eight weekly therapy sessions online or continue usual care. The goal is to see if the therapy helps them eat more variety and volume, improve symptoms, and gain weight.

What this could mean

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

Active substance
cognitive behavioral therapy (CBT)
What this could lead to
If it works, this could offer a structured therapy to help people with functional dyspepsia overcome food avoidance and regain weight.
What could go wrong
This is a small, early-stage trial with only 50 participants, so results may not apply widely. The therapy requires weekly sessions and may not work for everyone.

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 50 people

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

Started

Nov 2022

Expected to finish

May 2027

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 years and older

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 at least 18 years at screening visit * Rome IV Functional Dyspepsia post-prandial distress type (with or without epigastric pain syndrome) * Negative upper endoscopy or upper radiographic GI series to rule out structural/organic cause for FD * Avoidant/Restrictive Food Intake Disorder (ARFID) diagnosis (by the Structured Clinical Interview for DSM-5; SCID-5 at Screening visit) * ≥5% weight loss from weight after functional dyspepsia symptom onset (at Screening visit) * Stable for outpatient care (based on the American Psychiatric Association Practice Guideline for the Treatment of Patients with Eating Disorders) * No previous history of CBT for functional dyspepsia or ARFID * Computer/internet webcam access * Fluency in English * Stable dose for 30 days if on any medication Exclusion Criteria * Inability to provide informed consent * Presence of other conditions that could explain the patient's symptoms by chart: Pyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT) Active H.pylori infection (by CLO test or stool antigen test) Active inflammatory bowel disease Eosinophilic gastroenteritis or eosinophilic esophagitis Acute renal failure Chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis Acute liver failure Any acute gastrointestinal process Any plausible structural or metabolic causes Heartburn as predominant symptom History of peptic ulcer * Symptom resolution with antisecretory therapy (PPI use for other reasons that did not resolve FD symptoms will be allowed) * History of gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection) * History of any serious medical condition (e.g., cancer) * Use of narcotic analgesics greater than three days per week * Current pregnancy or breastfeeding within the last 8 weeks * Uncontrolled diabetes (indicated by HbA1c ≥7%) by chart * Intellectual disability by history * Current substance/alcohol use disorder within the past month * Current/history of psychosis (by Mini-International Neuropsychiatric Interview (MINI-Screen) * Current mania (by Mini-International Neuropsychiatric Interview (MINI-Screen) (defined as any manic episodes within the past 12 months) * Active suicidal ideation (by MINI-Screen) * Psychiatric disorder that would warrant independent attention (by Mini-International - Neuropsychiatric Interview (MINI-Screen)) * Current enteral or parenteral feeding * Plans to initiate another psychotherapy or pregnancy in the concurrent study period

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

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