RecruitingPhase 3NCT06274554

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

A Prospective, Randomized, Placebo-controlled Trial of Fluconazole in Combination With IL-23 Therapy Versus IL-23 Therapy Alone for the Treatment of Crohn's Disease


Sponsor

Weill Medical College of Cornell University

Enrollment

120 participants

Start Date

Oct 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an antifungal medication (fluconazole) to standard Crohn's disease treatment can improve how well the treatment works. Researchers think that fungal overgrowth in the gut may be interfering with Crohn's disease therapies. **You may be eligible if...** - You are at least 18 years old - You have mild to moderate Crohn's disease **You may NOT be eligible if...** - You have used antifungal medication in the past month - You are allergic to fluconazole - You have liver disease, cirrhosis, or abnormal liver blood tests - You take medications that dangerously interact with fluconazole - You are pregnant or breastfeeding - You have severe Crohn's disease or need surgery soon - You have narrowing (strictures) in your intestine causing symptoms - You have a pouch (pouchitis) or an ostomy - You have an active fungal infection - You have low potassium levels, advanced heart failure, or kidney problems Talk to your doctor to see if this trial is right for you.

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

DRUGFluconazole

Oral fluconazole capsules.

DRUGPlacebo

Oral placebo capsules will be used as a comparator.

BIOLOGICALIL-23 Therapy

Risankizumab (IL-23), Guselkumab (IL-23), or Ustekinumab (IL-12/23) as standard of care treatment.


Locations(1)

Weill Cornell Medicine

New York, New York, United States

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NCT06274554


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