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Could a common antidepressant soothe Crohn's gut woes?

NCT ID NCT07556718

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

Many people with Crohn's disease still have belly pain, bloating, or irregular bowel habits even when their disease is not active. This study tests whether a low dose of amitriptyline, a medication already used for irritable bowel syndrome, can safely reduce those symptoms. One hundred adults with quiescent Crohn's will receive either amitriptyline or a placebo for 24 weeks, and researchers will track side effects and symptom improvement.

What this could mean

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

Active substance
amitriptyline
What this could lead to
If it works, this could offer a safe, low-cost option to manage ongoing gut symptoms in people whose Crohn's disease is otherwise under control.
What could go wrong
This is a small phase 2 trial, so results may not be definitive. Amitriptyline can cause side effects like drowsiness or dry mouth, and the benefit over placebo is uncertain.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Started

Jun 2026

Expected to finish

Dec 2029

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, inclusive, at the time of consent. * Established diagnosis of Crohn's disease, confirmed by standard clinical, endoscopic, histologic, and/or radiologic criteria. * Quiescent Crohn's disease (qCD) defined by provider global assessment of remission for the last 3 months along with at least one of the following within the past 30 days: * Biochemical remission defined by fecal calprotectin \< 150 mcg/g, OR * Endoscopic remission defined by colonoscopy demonstrating Simple Endoscopic Scoring (SES)- Crohn's disease (CD) \< 4 per involved segment with no large ulcers (≥5 mm), and Rutgeerts score ≤ i1 (when applicable). OR * Radiographic evidence of quiescent disease consistent with the protocol. * Completion of a 12-lead electrocardiogram (ECG) within previous 12 months or at baseline demonstrating no clinically significant conduction abnormalities and a QTc ≤440 ms (males) or ≤460 ms (females). * Presence of Irritable Bowel Syndrome-like symptoms in the setting of quiescent disease (i.e., recurrent abdominal pain or discomfort on average at least 3 days per month in the past 3 months) and bowel dysfunction (i.e. either The Bristol Stool Form Scale (BSFS) 1-2 and/or 6-7) at least 25% of the time in the past 3 months. * At least mild-moderate abdominal pain defined by PROMIS Belly Pain score greater than or equal to 55. (PROMIS score may be re-assed once, 7 days after initial score is recorded * Stable Irritable Bowel Disease (IBD) medical therapy for at least the past 90 days (e.g., stable biologic, small molecule inhibitors or immunomodulator therapy with no planned changes or corticosteroids at enrollment). * Willingness to begin study medication using the amitriptyline self-titration schedule (10 mg → 50 mg as tolerated). * If personal history of anxiety and/or depression, stable dose of psychotropic medications for at least 6 months. * Willingness to use effective mode of contraception (e.g., OCP, IUD) for the duration of the study in women of child-bearing age. * Ability to complete electronic questionnaires, symptom diaries, and remote assessments using the REDCap platform. * Ability to provide written or electronic informed consent prior to participating in any study procedures. * Stable IBD medical therapy for at least the past 90 days (e.g., stable biologic, small molecule inhibitors or immunomodulator therapy with no planned changes or corticosteroids at enrollment). Exclusion Criteria: Crohn's Disease-Related Exclusions * Active Crohn's disease, based on objective markers, endoscopic activity, or radiologic inflammation. * Hospitalization for CD flare, bowel obstruction, or other significant disease activity within the protocol-defined timeframe prior to screening. * Actively draining perianal fistula or perianal abscess requiring antibiotics, the presence of a draining seton, intra-abdominal abscess requiring antibiotics or surgical or radiographic drainage, entero-cutaneous fistula requiring active management, or other complications suggesting active inflammation. * Any clinically significant stricture that could explain the IBS-like symptoms * The presence of an ileostomy or colostomy. * The presence of a J-pouch or other stool continent pouch (e.g., Koch pouch, continent ileostomy). Medication-Related Exclusions * Current use of tricyclic antidepressants (TCAs). * Current use of monoamine oxidase inhibitors (MAOIs) or other medications that have a clinically significant interaction with amitriptyline. * Current use of Cisapride. * History of hypersensitivity or allergy to amitriptyline or other TCAs. * Planned change in IBD maintenance therapy during the study period. Cardiac and Safety Exclusions * Known cardiac conduction abnormalities, including: * Prolonged QT interval defined as QTc \>440 ms in males or \>460 ms in females in previous 12 months or baseline ECGHistory of cardiac arrythmias, including Brugada syndrome, currently taking guanethidine or recent use of guanethidine in the past 14 days * Recent history of myocardial infarction in the past 3 months * Use of medications that significantly prolong QT interval (e.g., amiodarone, terfenadine, or sotalol), unless deemed safe by study medical oversight. Psychiatric / Neurologic Exclusions * Evidence of active major depressive disorder, defined by depression score greater than or equal to 11 on the Hospital Anxiety and Depression Scale (HADS) * History of bipolar disorder, schizophrenia, obsessive-compulsive disorder, or other severe psychiatric conditions that may interfere with study participation * Active or passive suicidal ideation in the last 3 months. * Hospitalization for any psychiatric illness in the last year. * Personal history of seizures. * Currently taking a monoamine oxidase inhibitor (MAOI) or recent use of MAOI in the last 14 days. Other Medical Exclusions * Pregnancy, breastfeeding, or plans to become pregnant during the study period. * Positive urine pregnancy test at screening, if applicable. * History of angle-closure glaucoma. * History of urinary retention requiring hospitalization or emergency department (ED) visit in the last 6 months. * Current or recent substance use disorder that may interfere with participation. * Participation in another interventional clinical trial within the exclusion window * Inability or unwillingness to comply with study visits, medication instructions, electronic assessments, or follow-up requirements. * Any condition that, in the investigator's opinion, would interfere with the study or pose undue risks to the participant.

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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 places running it

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

  2. 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 ↗

  3. 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

Locations

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States