Not Yet RecruitingPhase 2

Duloxetine in Inflammatory Bowel Diseases

32 participantsStarted 2026-05-01

Plain-language summary

This open-label, prospective, single-arm pilot study investigates the use of duloxetine, a central neuromodulator, for improving psychological distress and functional impairment in adults with inflammatory bowel disease (IBD). The study focuses on patient-reported outcomes related to anxiety, depression, and IBD-related disability, aiming to assess feasibility, tolerability, and preliminary efficacy in modulating gut-brain axis symptoms and disease-related functional impairments in life

Who can participate

Age range24 Years

SexALL

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Inclusion criteria

✓. elevated psychological distress (Distress Thermometer score \> 4),10-12
✓. moderate-to-severe IBD-related disability (IBD-DI score ≥ 356, 7), or
✓. elevated GI-specific anxiety (Visceral Sensitivity Index \> 10) -

What they're measuring

Change in IBD-related disability

Timeframe: 6 weeks

Trial details

NCT IDNCT07431606

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-01

Contact for this trial

Chung Tse, MD

2153498222 Chung.Tse@Pennmedicine.upenn.edu

View on ClinicalTrials.gov More Inflammatory Bowel Diseases trials