RecruitingPhase 2NCT07556718

Amitriptyline for IBS-like Symptoms in Quiescent Crohn's Disease

Amitriptyline for IBS-like Symptoms in Quiescent Crohn's Disease: A Multicenter Randomized Placebo-Controlled Trial


Sponsor

University of Michigan

Enrollment

100 participants

Start Date

Jun 3, 2026

Study Type

INTERVENTIONAL

Conditions

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. This study will assess whether amitriptyline is safe and reduces those ongoing GI symptoms in adults with Crohn's disease in remission.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Amitriptyline and a drug called Placebo for people with quiescent crohn's disease (cd). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmitriptyline

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.

DRUGPlacebo

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.


Locations(1)

University of Michigan

Ann Arbor, Michigan, United States

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NCT07556718