University of Michigan
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.
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…
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.
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.
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