Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06274554

Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease

Led by Weill Medical College of Cornell University · Updated on 2025-10-01

120

Participants Needed

1

Research Sites

269 weeks

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

T

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to start or are currently undergoing standard of care treatment and plan to dose-escalate an IL-23 therapy for their Crohn's disease. The main question it aims to assess is whether or not patient response to IL-23 therapies improve when simultaneously treated with fluconazole.

CONDITIONS

Official Title

Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients at least 18 years old
  • Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450
Not Eligible

You will not qualify if you...

  • Antifungal use within one month before starting fluconazole treatment
  • Known allergy to fluconazole
  • Known liver disease, cirrhosis, or elevated liver tests above specified limits
  • Use of medications that interact with fluconazole causing serious side effects
  • Pregnant or breastfeeding women
  • Severe Crohn's disease or need for surgery as determined by physician
  • Symptomatic stricturing
  • Presence of pouchitis or ostomy
  • Active fungal infections requiring special treatment
  • Low potassium levels or advanced heart failure
  • Kidney problems

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Weill Cornell Medicine

New York, New York, United States, 10065

Actively Recruiting

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Research Team

C

Caroline Ericsson, BS

CONTACT

A

Aurelia Li, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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