RECRUITING

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

Conditions

Crohn's Disease Inflammatory Bowel Diseases Fluconazole IL-23

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-04

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06274554

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients at least 18 years old 2. Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450 3. Besides the biologics of interest in this study, subjects must be on stable dosing of any therapy for at least 4 weeks prior to treatment initiation. Including: 1. Steroids (9 mg or less of budesonide, 20 mg or less of prednisone) 2. Mesalamines 3. Immunomodulators 4. Biologics 5. Other medications for IBD (inflammatory bowel disease)	1. Antibiotic usage within one month prior to initiation of blinded fluconazole usage 2. Antifungal usage within one month prior to initiation of blinded fluconazole usage 3. Known allergy to fluconazole 4. Patients with known hepatic disease, cirrhosis, or with elevated liver biochemistries (e.g., transaminase(s) \>3X upper limit of normal (ULN), and/or bilirubin levels \>1.5X ULN (with exception of confirmed Gilbert's disease) at baseline 5. Patients taking medications known to interact with fluconazole and cause serious adverse events, including but not limited to death, cardiac events, serious cardiac dysrhythmias, and prolongation of QTc (corrected QT interval) 6. Pregnant or lactating women 7. Severe Crohn's disease defined by a PRO-2 score ≥ 34 (patient reported outcomes) or imminent need for surgery, or deemed not medically fit by physician 8. Patient with symptomatic stricturing 9. Patient with pouchitis or an ostomy 10. Patients with known, active fungal, or other, infection(s) since these patients would require particular, standard-of-care monitoring and treatment, which may include intravenous and/or prolonged courses of fluconazole or other therapies. 11. Patients with hypokalemia, or advanced cardiac failure 12. Patients with renal insufficiency

Inclusion Criteria

Exclusion Criteria

1. Patients at least 18 years old
2. Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450
3. Besides the biologics of interest in this study, subjects must be on stable dosing of any therapy for at least 4 weeks prior to treatment initiation. Including:
1. Steroids (9 mg or less of budesonide, 20 mg or less of prednisone)
2. Mesalamines
3. Immunomodulators
4. Biologics
5. Other medications for IBD (inflammatory bowel disease)

1. Antibiotic usage within one month prior to initiation of blinded fluconazole usage
2. Antifungal usage within one month prior to initiation of blinded fluconazole usage
3. Known allergy to fluconazole
4. Patients with known hepatic disease, cirrhosis, or with elevated liver biochemistries (e.g., transaminase(s) \>3X upper limit of normal (ULN), and/or bilirubin levels \>1.5X ULN (with exception of confirmed Gilbert's disease) at baseline
5. Patients taking medications known to interact with fluconazole and cause serious adverse events, including but not limited to death, cardiac events, serious cardiac dysrhythmias, and prolongation of QTc (corrected QT interval)
6. Pregnant or lactating women
7. Severe Crohn's disease defined by a PRO-2 score ≥ 34 (patient reported outcomes) or imminent need for surgery, or deemed not medically fit by physician
8. Patient with symptomatic stricturing
9. Patient with pouchitis or an ostomy
10. Patients with known, active fungal, or other, infection(s) since these patients would require particular, standard-of-care monitoring and treatment, which may include intravenous and/or prolonged courses of fluconazole or other therapies.
11. Patients with hypokalemia, or advanced cardiac failure
12. Patients with renal insufficiency

Contacts and Locations

Study Contact

Grace Xiang, BS

CONTACT

646-697-0985

grx4001@med.cornell.edu

Caroline Ericsson, BS

CONTACT

646-697-0985

cae4007@med.cornell.edu

Principal Investigator

Randy Longman, MD, PhD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Randy Longman, MD, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-04

Study Completion Date2029-12

Study Record Updates

Study Start Date2024-10-04

Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

Fluconazole
IL-23

Additional Relevant MeSH Terms

Crohn's Disease
Inflammatory Bowel Diseases