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

Conditions

• Quiescent Crohn's Disease (CD)

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Amitriptyline — DRUG
  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 — DRUG
  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 Details

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.

Key Dates

Start date

Jun 3, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Amitriptyline
  Roughly 50 participants
• Placebo Comparator: Placebo
  Roughly 50 participants

Primary Outcome Measure

Safety reported as the proportion of participants experiencing a serious adverse event (SAE), [ Time Frame: Week 24 ]

Central Contacts

• Charlie Bourque Jr.
  (734) 615-3911
  [email protected]
• Allen A. Lee, MD, MS
  (734) 936-9454
  [email protected]

Locations (1)

Find similar trials in Ann Arbor, MI