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Targeting the Mycobiome in Genetically Defined Patients with Crohns Disease

Award Number: R01DK125495
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2021
PERIOD OF PERFORMANCE END DATE: 02/28/2026

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Targeting the Mycobiome in Genetically Defined Patients with Crohns Disease - ABSTRACT Inflammatory bowel disease (IBD), divided largely into Crohn’s Disease (CD) and ulcerative colitis, is a chronic and serious disease that results from dysregulated inflammatory immune activity in the mucosa of the gastrointestinal tract. There has been much progress defining genetic, intestinal microbiome, host pathway, and environmental roles in disease, and a major goal in IBD research and care is to translate these observations into strategies to improve outcomes by better matching disease treatment with patients’ specific underlying mechanisms of disease. Studies on the role of the microbiome in influencing IBD have focused largely on the bacterial microbiota, while the potential role for commensal fungal microbiota to influence disease has been largely overlooked. We recently reported a strong association of the yeast Malassezia with Crohn’s Disease. Specifically, intestinal mucosa- associated Malassezia are elevated in patients carrying a previously described IBD risk polymorphism (S12N) in the gene for CARD9, a signaling molecule require for antifungal inflammatory immune responses. In mouse models, Malassezia exacerbates colitis via a mechanism requiring CARD9. This project is designed to test the hypothesis that oral antifungal treatment can reduce the burden of Malassezia spp. in CD patients with the CARD9 S12N allele and improve disease symptoms. The approach includes a two-center randomized, double- blind, placebo-controlled study of antifungal drug treatment in genetically defined patients with active Crohn’s disease. We will evaluate the consequences of antifungal drug treatment on the overall microbiome and metabolites it produces as well as regulation of immune cell function in the mucosa.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $548,343 )
2025	2025	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	5/7/2025	NON-COMPETING CONTINUATION	$548,343
														Subtotal = $548,343

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	5/20/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $633,061 )
2023	2023	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	2/28/2023	NON-COMPETING CONTINUATION	$633,061
														Subtotal = $633,061

Issue Date FY: 2022 ( Subtotal = $640,531 )
2022	2022	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	3/29/2022	NON-COMPETING CONTINUATION	$640,531
														Subtotal = $640,531

Issue Date FY: 2021 ( Subtotal = $691,474 )
2021	2021	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	4/28/2021	NEW	$691,474
														Subtotal = $691,474

Grand Total All Awards = $2,513,409

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Targeting the Mycobiome in Genetically Defined Patients with Crohns Disease

Award Number: R01DK125495

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/01/2021

PERIOD OF PERFORMANCE END DATE: 02/28/2026

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