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Stratification of ME/CFS by mycotoxin exposure

Award Number: R01NS148845
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/08/2026
PERIOD OF PERFORMANCE END DATE: 04/30/2031

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Stratification of ME/CFS by mycotoxin exposure - Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a disabling, multisystem disease affecting up to 3.3 million Americans, predominantly women. Despite a significant public health burden, biological mechanisms remain poorly understood and no diagnostic biomarkers or targeted therapies exist. Mounting evidence suggests that environmental exposures, particularly to fungal mycotoxins, may contribute to ME/CFS pathogenesis by promoting immune dysfunction. However, there are no peer-reviewed published studies examining the molecular effects of mycotoxins on the immune system of ME/CFS patients. This proposal aims to conduct the first study on the molecular level of how mycotoxin exposure contributes to ME/CFS pathophysiology. We hypothesize that mycotoxins induce transcriptomic reprogramming in immune cells and extracellular vesicles (EVs), leading to immune exhaustion and chronic inflammation. Preliminary data from our group shows enrichment of fungal-response pathways, altered immune cell subsets, increased pro-inflammatory EV miRNAs, and exhaustion-associated signatures in ME/CFS patients with detectable urinary mycotoxins. We will recruit 150 ME/CFS patients and 50 matched sedentary healthy controls (HC), stratify ME/CFS cases by mycotoxin exposure, and pursue four specific aims: Aim 1: Quantify urinary mycotoxins and assess associations of mycotoxin levels and combinations with symptom severity and plasma cytokines. Aim 2: Use single-cell RNA sequencing to define mycotoxin contribution to transcriptomic alterations in PBMC subsets in ME/CFS patients. Aim 3: Identify long and small RNA signatures in plasma-derived EVs associated with mycotoxin exposure. Aim 4: Integrate multi-omics data using machine learning to identify mechanistic correlations between mycotoxin exposure, immune dysregulation, and symptom severity. We will use a validation cohort of 20 ME/CFS patients and 10 HC to confirm our results. Our approach is innovative in combining environmental exposure data with transcriptomics and EV RNA profiling to define a biologically and clinically distinct ME/CFS subgroup. The integration of scRNA-seq, EV-RNA profiles, and urinary mycotoxins will enable the discovery of robust molecular signatures and mechanistic pathways affected by environmental toxins, namely mycotoxins. This work will significantly advance the field by providing stratification of ME/CFS by mycotoxin exposure and providing novel insights into environmentally driven immune reprogramming in ME/CFS. Outcomes include identification of candidate biomarkers, deeper understanding of the contribution of mycotoxins to immune exhaustion mechanisms, and a stratification framework for future diagnostics and therapeutic interventions. Our study represents a critical step toward developing precision medicine strategies for ME/CFS patients with environmentally exacerbated disease symptoms.


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: 2026 ( Subtotal = $614,458 )
2026	2026	NOVA SOUTHEASTERN UNIVERSITY, INC	3300 S UNIVERSITY DR	FT LAUDERDALE	FL	33328	BROWARD	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	5/12/2026	NEW	$614,458
														Subtotal = $614,458

Grand Total All Awards = $614,458

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Stratification of ME/CFS by mycotoxin exposure

Award Number: R01NS148845

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/08/2026

PERIOD OF PERFORMANCE END DATE: 04/30/2031

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