Quiescent Crohn's Disease (CD)Phase 2AIMS-CDNCT07556718
Amitriptyline for IBS-like Symptoms in Quiescent Crohn's Disease
A Phase 2 study testing Amitriptyline in people with Quiescent Crohn's Disease (CD), run by University of Michigan at 1 site in United States.
Trial summary
Many individuals with Crohn's disease continue to experience abdominal pain, bloating, or bowel habit changes even when their inflammation is controlled. Amitriptyline is a medication commonly used at low doses to treat irritable bowel syndrome (IBS) and abdominal pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quiescent Crohn's Disease (CD)
- What is being tested?
- Amitriptyline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2026to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Allen A. Lee, MD, MS, 734-936-9454, allenlee@med.umich.edu
About this study
Official title: Amitriptyline for IBS-like Symptoms in Quiescent Crohn's Disease: A Multicenter Randomized Placebo-Controlled Trial
Many individuals with Crohn's disease continue to experience abdominal pain, bloating, or bowel habit changes even when their inflammation is controlled. Amitriptyline is a medication commonly used at low doses to treat irritable bowel syndrome (IBS) and abdominal pain. This study will assess whether amitriptyline is safe and reduces those ongoing GI symptoms in adults with Crohn's disease in remission.
- Conditions
- Quiescent Crohn's Disease (CD)
- Being tested
- Amitriptyline, Placebo
- Keywords
- Tricyclic antidepressants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
Amitriptyline will be administered orally once daily. It will be dispensed in capsules or tablets that are visually identical to placebo.
Self-titration schedule beginning at 10 mg and increasing to a maximum of 50 mg over the first six weeks, as tolerated. Participants will continue their maximum tolerated dose through Week 24.
PlaceboDrug
Placebo capsules or tablets will be visually indistinguishable from amitriptyline to maintain participant and investigator blinding.
Self-titration schedule beginning at 10 mg and increasing to a maximum of 50 mg over the first six weeks, as tolerated. Participants will continue their maximum tolerated placebo dose through Week 24.
| Study group | Role | What they receive |
|---|---|---|
| Amitriptyline | Experimental | Roughly 50 participants Receives: Drug: Amitriptyline |
| Placebo | Placebo comparator | Roughly 50 participants Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety reported as the proportion of participants experiencing a serious adverse event (SAE),
An SAE is defined as an adverse events resulting in hospitalization or emergency department visit and/or suicidal ideation or hallucinations that are considered "probably" or "definitely" related to the study-drug.
Measured: Week 24
Secondary outcomes (2)
Efficacy in Abdominal Pain
Assessed using the PROMIS Belly Pain score which range from 5-25 and higher scores indicate worse symptoms.
Measured: Week 24
Global Symptom Improvement
Assessed using The Irritable Bowel Severity Scoring System (IBS-SSS) is a questionnaire used for evaluating the severity of IBS with a maximum score of 500. Higher scores indicate increased pain.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start3 Jun 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quiescent Crohn's Disease (CD)Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, randomized, double-blind, placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Principal investigator, Allen Lee, University of Michigan
- Investigators
- Allen A. Lee, MD, MS, Principal investigator, University of MichiganShrinivas Bishu, MD, Principal investigator, University of MichiganPrashant Singh, MD, Principal investigator, University of MichiganKinza Tareen, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556718
- Sponsor's protocol ID
- HUM00265477
- Acronym
- AIMS-CD
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amitriptyline for IBS-like Symptoms in Quiescent Crohn's Disease: A Multicenter Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07556718
- Acronym / sponsor ID
- AIMS-CD / HUM00265477
- Conditions
- Quiescent Crohn's Disease (CD)
- Keywords
- Tricyclic antidepressants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many individuals with Crohn's disease continue to experience abdominal pain, bloating, or bowel habit changes even when their inflammation is controlled. Amitriptyline is a medication commonly used at low doses to treat irritable bowel syndrome (IBS) and abdominal pain. This study will assess whether amitriptyline is safe and reduces those ongoing GI symptoms in adults with Crohn's disease in remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multicenter, randomized, double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Amitriptyline | Experimental | Drug: AmitriptylineRoughly 50 participants |
| Placebo | Placebo comparator | Drug: PlaceboRoughly 50 participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmitriptylineAmitriptyline will be administered orally once daily. It will be dispensed in capsules or tablets that are visually identical to placebo. Self-titration schedule beginning at 10 mg and increasing to a maximum of 50 mg over the first six weeks, as tolerated. Participants will continue their maximum tolerated dose through Week 24. | Drug | Amitriptyline |
| PlaceboPlacebo capsules or tablets will be visually indistinguishable from amitriptyline to maintain participant and investigator blinding. Self-titration schedule beginning at 10 mg and increasing to a maximum of 50 mg over the first six weeks, as tolerated. Participants will continue their maximum tolerated placebo dose through Week 24. | Drug | Placebo |
Primary outcome
Safety reported as the proportion of participants experiencing a serious adverse event (SAE),
Time frame: Week 24
An SAE is defined as an adverse events resulting in hospitalization or emergency department visit and/or suicidal ideation or hallucinations that are considered "probably" or "definitely" related to the study-drug.
2 secondary outcomes
Efficacy in Abdominal Pain
Time frame: Week 24
Global Symptom Improvement
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allen A. Lee, MD, MS principal investigator
University of Michigan
Shrinivas Bishu, MD principal investigator
University of Michigan
Prashant Singh, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amitriptyline in people with Quiescent Crohn's Disease (CD), run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlie Bourque Jr. ((734) 615-3911, cabjr@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety reported as the proportion of participants experiencing a serious adverse event (SAE), (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.