Could a common antidepressant soothe Crohn's gut woes?
NCT ID NCT07556718
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Quiescent Crohn's disease (CD) are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGAnn Arbor, Michigan, 48109, United States