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Fecal microbial transplantation for chemotherapy behavioral side effects

Award Number: R01CA287261
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2024
PERIOD OF PERFORMANCE END DATE: 01/31/2029

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Fecal microbial transplantation for chemotherapy behavioral side effects - PROJECT SUMMARY/ABSTRACT Mental side effects of chemotherapy reduce quality of life and treatment dosing, thereby increasing mortality. Current supportive care treatments are ineffective, thus identifying new interventions to prevent or reduce these adverse side effects are crucial. We and others have recently hypothesized that gut dysbiosis may contribute to the behavioral side effects of chemotherapy. Our long-term goal is develop novel microbial-based treatments for the devastating side effects of the large and growing populations of chemotherapy-treated patients. The gut microbial community is dramatically altered by chemotherapy and has recently been shown to communicate with the brain to affect behavior. Indeed, we have previously published that altered composition of the gut microbiota due to chemotherapy in mice drives central and systemic inflammation resulting in selective behavioral side effects. Thus, the overall objective here is to determine the potential and feasibility of using fecal microbial trans- plant (FMT) as an intervention for chemotherapy behavioral side effects. Three specific aims are proposed to study this objective using our murine chemotherapy model (Aims 1 & 2) and a feasibility pilot clinical trial in breast cancer patients receiving chemotherapy (Aim 3). Aim 1 will quantify the efficacy of healthy FMTs in ameliorating sickness and cognitive behaviors during chemotherapy. Efficacy of autoFMT, alloFMT, or saline delivered in a preventative or therapeutic paradigm on sickness and cognitive behaviors will be assessed during chemotherapy treatment in mice after mammary tumor resection. Aim 2 will identify the systemic and neurobiological correlates of FMT interventions during chemotherapy. The efficacy of the FMT treatments on systemic and central inflam- matory signals, and the specific role of microglia, will be assessed during chemotherapy in mice after tumor resection. Aim 3 will pilot the feasibility of investigating the therapeutic potential for FMT to alleviate behavioral and gastrointestinal chemotherapy side effects in early-stage breast cancer patients. A small group of patients receiving chemotherapy will undergo an autoFMT or standard of care. Side effects will be assessed before and after FMT. The proposed research is conceptually innovative and our interdisciplinary team will be the first to use novel therapeutic FMT for chemotherapy-induced behavioral side effects in a combined basic and clinical approach. This research project will provide the necessary mechanistic and clinical foundation for future pro- posals focused on larger clinical FMT trials. This is the first step along a microbial research arc that has the potential to alter how common chemotherapy drugs are administered.


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 = $546,270 )
2026	2026	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Cancer Treatment Research	000	3	2/2/2026	NON-COMPETING CONTINUATION	$546,270
														Subtotal = $546,270

Issue Date FY: 2025 ( Subtotal = $601,697 )
2025	2025	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Cancer Treatment Research	001	2	6/2/2025	NON-COMPETING CONTINUATION	$60,169
2025	2025	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Cancer Treatment Research	000	2	1/16/2025	NON-COMPETING CONTINUATION	$541,528
														Subtotal = $601,697

Issue Date FY: 2024 ( Subtotal = $615,068 )
2024	2024	OHIO STATE UNIVERSITY, THE	1960 KENNY RD	COLUMBUS	OH	43210	FRANKLIN	USA	Cancer Treatment Research	000	1	1/18/2024	NEW	$615,068
														Subtotal = $615,068

Grand Total All Awards = $1,763,035

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Fecal microbial transplantation for chemotherapy behavioral side effects

Award Number: R01CA287261

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/01/2024

PERIOD OF PERFORMANCE END DATE: 01/31/2029

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