Crohn's Disease Research Study

Researchers at the University of Michigan and partnering institutions are conducting a study on low-dose amitriptyline for abdominal pain or discomfort in adults with Crohn’s disease that is under control.

Fast Facts

Diagnosed with Crohn's Disease & have at least mild-moderate severity of abdominal pain

Crohn's Disease is currently under control

Compensation

provided up to $250

Conducted in

Ann Arbor, MI

Study Background

This clinical trial is studying whether low-dose amitriptyline can safely improve abdominal pain or discomfort in people with Crohn’s disease who are in remission.

Up to 40% of people with Crohn’s disease continue to experience ongoing abdominal pain and bowel changes even when their inflammation is under control. These symptoms can significantly impact daily life and overall quality of life. Currently, there are no evidence-based treatments specifically for patients with controlled Crohn’s disease who still experience these symptoms.

The AIMS-CD Trial (Amitriptyline for IBS-like Symptoms in Crohn’s Disease) is a study evaluating whether low-dose amitriptyline, a medication that may help reduce abdominal pain or discomfort, can improve symptoms in this population. Participants will receive either amitriptyline or a placebo for six months to assess tolerability, adherence, and symptom improvement.

Study Background

This clinical trial is studying whether low-dose amitriptyline can safely improve abdominal pain or discomfort in people with Crohn’s disease who are in remission.

Up to 40% of people with Crohn’s disease continue to experience ongoing abdominal pain and bowel changes even when their inflammation is under control. These symptoms can significantly impact daily life and overall quality of life. Currently, there are no evidence-based treatments specifically for patients with controlled Crohn’s disease who still experience these symptoms.

The AIMS-CD Trial (Amitriptyline for IBS-like Symptoms in Crohn’s Disease) is a study evaluating whether low-dose amitriptyline, a medication that may help reduce abdominal pain or discomfort, can improve symptoms in this population. Participants will receive either amitriptyline or a placebo for six months to assess tolerability, adherence, and symptom improvement.

Additional Information

This study aims to determine if a new medication may help reduce abdominal pain or discomfort.

You may be eligible for this study if you meet the following criteria.

Inclusion Criteria:

  • Crohn’s disease that is under control
  • Mild to moderate severity of abdominal pain or discomfort
  • Stable IBD medications for at least the past 90 days
  • No use of steroid medications for Crohn’s disease within the past 90 days
  • Complete a phone screening to determine eligibility

  • Attend a baseline in-person visit (Week 0)

  • Be randomized to receive either amitriptyline or placebo for 6 months

  • Attend virtual follow-up visits at Week 2 and Months 1, 3, and 6

  • Complete brief monthly online surveys to monitor safety and symptoms

Participants can receive up to $250 for completing the study.

There is no cost for you to participate in our research study.