The Montreal Heart Institute is inviting you to participate in a study to evaluate the effects of a
combination of antifungal drugs called terbinafine and itraconazole to treat Crohn's Disease.

The development of inflammation during Crohn's disease is linked to the presence of complex intestinal microorganisms, called microbiota.
This microbiota can be composed of bacteria and fungi. The yeasts have the ability to adhere to the intestinal walls and cause a local immune reaction in the intestine causing inflammation.

Terbinafine is a drug that has been used for many years to treat certain types of fungal infections of the skin and nails.

Itraconazole is used to treat certain forms of fungal infections, both internal (inside the body) and
external (on the skin). It exerts an action that prevents fungi from reproducing.

The objective of the CD-IT study is to evaluate the response to the combination of these two antifungals in patients with Crohn's disease who do not respond adequately to current therapy.

This research project is approximately 28 weeks (7 months) in duration, divided into 6 visits plus a
follow-up phone call. The treatment period is 20 weeks (5 months) using the combination of two
antifungal drugs or placebos.

WHO: Adults between 18-65 years with active Crohn's disease, with Harvey-Bradshaw Index (HBI) ≥ 5 to ≤16.

Montreal area or Sherbrooke area

Primary Contact
Julie Fleury
Julie.fleury.chum@ssss.gouv.qc.ca

Principal Investigators
Jean-Claude Tardif
Montreal Heart Institute

Edmond-Jean Bernard
University of Montreal Health Centre (CHUM)