Phase 2 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 65 years at the time of giving consent.
• People who have a confirmed diagnosis of Crohn's disease, established through standard medical testing such as scopes, imaging, or lab results.
• People whose Crohn's disease has been in remission (inactive) for the past 3 months according to their doctor, supported by at least one recent test result — such as a stool inflammation marker below a certain level, a recent colonoscopy showing low disease activity, or imaging showing quiet disease.
• People who have had a heart tracing (ECG) done within the past 12 months or at the start of the study, showing no significant heart rhythm problems and a heart interval measurement (QTc) within the normal range for their sex.
• People who have ongoing gut symptoms similar to irritable bowel syndrome — such as recurring abdominal pain or discomfort on at least 3 days per month over the past 3 months — along with abnormal stool consistency (very hard or very loose stools) at least 25% of the time over those 3 months, despite their Crohn's disease being inactive.
• People with at least mild to moderate abdominal pain, as measured by a specific pain questionnaire (PROMIS Belly Pain score of 55 or above). This score may be re-checked once, 7 days after the first measurement.
• People who have been on a stable Crohn's disease treatment plan for at least the past 90 days, with no planned changes to that treatment.
• People who are willing to take the study medication (amitriptyline), starting at a low dose and gradually increasing as tolerated.
• People with a personal history of anxiety or depression who have been on a stable dose of mental health medication for at least 6 months.
• Women of childbearing age who are willing to use an effective form of contraception for the full duration of the study.
• People who are able to complete online questionnaires, symptom diaries, and remote check-ins using the study's digital platform.
• People who are able to give written or electronic consent before taking part in any study activities.

Who may not be able to join:

• People whose Crohn's disease is currently active, based on test results, scope findings, or imaging showing inflammation.
• People who have been hospitalised due to a Crohn's flare, bowel blockage, or other significant disease activity within a recent period before screening (confirm timeframe with trial site).
• People with an actively draining fistula or abscess near the anal area requiring antibiotics, a draining surgical thread (seton), an abscess inside the abdomen requiring antibiotics or drainage, a fistula through the skin requiring active management, or other signs of active inflammation.
• People with a significant narrowing (stricture) in their bowel that could explain their gut symptoms.
• People who have a stoma bag (ileostomy or colostomy).
• People who have had a surgical internal pouch created from bowel tissue (such as a J-pouch or Koch pouch).
• People currently taking a class of antidepressants called tricyclic antidepressants (TCAs).
• People currently taking a type of antidepressant called monoamine oxidase inhibitors (MAOIs), or other medications known to interact significantly with the study drug (amitriptyline).
• People currently taking a medication called Cisapride.
• People with a known allergy or hypersensitivity to amitriptyline or related medications (TCAs).
• People who have a planned change in their Crohn's disease treatment during the study period.
• People with known heart conduction problems, including a prolonged QTc interval on a heart tracing, a history of heart rhythm disorders (including a condition called Brugada syndrome), or who are currently taking or have recently taken a medication called guanethidine within the past 14 days.
• People who have had a heart attack in the past 3 months.
• People taking medications known to significantly affect heart rhythm (such as amiodarone, terfenadine, or sotalol), unless the study medical team determines it is safe to participate.
• People with signs of active major depression, as indicated by a score of 11 or above on a standard anxiety and depression questionnaire (HADS).
• People with a history of bipolar disorder, schizophrenia, obsessive-compulsive disorder, or other serious psychiatric conditions that may affect their ability to take part in the study.
• People who have had thoughts of suicide (active or passive) in the past 3 months.
• People who have been hospitalised for a psychiatric illness in the past year.
• People with a personal history of seizures.
• People who have taken an MAOI antidepressant in the past 14 days.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study.
• People with a positive pregnancy test at screening, where applicable.
• People with a history of a specific type of eye condition called angle-closure glaucoma.
• People who have needed hospital or emergency care for difficulty urinating (urinary retention) in the past 6 months.
• People with a current or recent substance use disorder that may affect their ability to take part.
• People currently enrolled in another interventional clinical trial within a certain time period before this study (confirm timeframe with trial site).
• People who are unable or unwilling to attend study visits, follow medication instructions, complete digital assessments, or meet follow-up requirements.
• People with any other condition that the study doctor considers would interfere with the study or create unacceptable risk.

Important: Always verify eligibility with the trial site directly before applying.