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Microbial, immune, metabolic perturbations by antibiotics (MIME study)

Award Number: U01AI122285
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2019
PERIOD OF PERFORMANCE END DATE: 12/31/2026

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Microbial, immune, metabolic perturbations by antibiotics (MIME study) - Project Summary Over 250 million courses of antibiotics are prescribed annually to out-patients in the United States. The perception that antibiotic use has minimal adverse side effects contributes to their over-use. Since deploying antibiotics seems to be relatively free of toxicity, there are few disincentives to their use even when perceived benefits are marginal. Recent understanding of the human microbiome suggests the relevance of antibiotic exposures to health, with the emerging view that our microbiota are central to human physiology. In animal models, perturbing the microbiota affects metabolic, immune, and cognitive physiology. Antibiotics diffuse into all body compartments, selecting for resistance. We propose to examine the effects of two commonly used antibiotics, a beta-lactam (amoxicillin)and a macrolide (azithromycin) on microbial populations and on metabolic and immune physiology, in healthy volunteers in a prospective randomized clinical trial conducted at the NIH Clinical Center (CC). We hypothesize that in addition to acutely perturbing the human microbiome, these agents will have measurable metabolic and immunologic effects, with effects continuing over the following weeks and months. To test this hypothesis, in Aim 1, we assess the effects of a brief therapeutic antibiotic course on microbiota and metagenome composition. After initial evaluation, antibiotics are given for 5-7 days, with a prolonged post-treatment evaluation. Specimens are obtained from multiple sites at each of 10 time-points and used to estimate bacterial and fungal composition and gene content. In Aim 2, we assess the effects of the antibiotic course on immune physiology. At multiple time points, blood is obtained and used to determine plasma and cellular levels of markers of both innate and adaptive immunity. In Aim 3, we assess the effects of the antibiotic course on metabolic physiology. The specimens obtained are assessed for markers of metabolic and hormonal physiology. A subset of subjects enter the unique CC Metabolic Chamber to quantify 24-hour energy expenditure and carbohydrate and fat utilization. In addition to the primary data analyses, we will build an informatic model integrating the temporal data to provide insight into the complex interdependent physiology between microbiome and host. This project is an opportunity to perform comprehensive and integrated evaluations of two pharmacologic agents prescribed >90 million times annually in the USA. Careful analysis and development of an integrated model to understand the pathophysiology of the perturbations may identify problems below the radar in clinical medicine. The purpose of this renewal is to recruit sufficient numbers of subjects to complete the study after the interruption caused by COVID-19 and the subsequent COVID studies in the Clinical Center. Increasing the number of subjects to ~20 per group will permit robust analyses of the extent and duration of microbiome changes due to the antibiotic perturbations, and their consequent effects on host metabolic and immune functionalities, and their interactions; the present limitations in numbers of participants constrain a thorough analysis.


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 = $443,788 )
2026	2026	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	000	9	1/13/2026	NON-COMPETING CONTINUATION	$443,788
														Subtotal = $443,788

Issue Date FY: 2025 ( Subtotal = $391,307 )
2025	2025	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	000	8	1/7/2025	NON-COMPETING CONTINUATION	$430,474
2025	2021	RUTGERS, THE STATE UNIVERSITY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	001	6	1/21/2025	NON-COMPETING CONTINUATION	$0
2025	2020	RUTGERS, THE STATE UNIVERSITY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	002	5	2/3/2025	SUPPLEMENT FOR EXPANSION	-$39,167
														Subtotal = $391,307

Issue Date FY: 2024 ( Subtotal = $458,038 )
2024	2024	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	002	7	9/12/2024	COMPETING CONTINUATION	$44,379
2024	2024	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	001	7	2/26/2024	COMPETING CONTINUATION	$413,659
2024	2021	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	6	2/23/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $458,038

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	6	3/23/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	5	8/11/2022	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $340,550 )
2021	2021	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	6	4/19/2021	NON-COMPETING CONTINUATION	$340,550
2021	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	001	5	5/3/2021	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $340,550

Issue Date FY: 2020 ( Subtotal = $1,904,768 )
2020	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	003	5	5/13/2020	SUPPLEMENT FOR EXPANSION	$1,558,030
2020	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	002	5	5/5/2020	NON-COMPETING CONTINUATION	$346,738
2020	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	004	5	6/4/2020	NON-COMPETING CONTINUATION	$0
2020	2019	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	001	4	3/24/2020	EXTENSION WITH OR WITHOUT FUNDS	$258,702
2020	2018	NEW YORK UNIVERSITY	550 1ST AVE	NEW YORK	NY	10016	NEW YORK	USA	Allergy and Infectious Diseases Research	000	3	3/24/2020	NON-COMPETING CONTINUATION	-$258,702
														Subtotal = $1,904,768

Issue Date FY: 2019 ( Subtotal = $366,946 )
2019	2019	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	001	4	4/30/2019	EXTENSION WITH OR WITHOUT FUNDS	$249,738
2019	2019	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	002	4	5/31/2019	EXTENSION WITH OR WITHOUT FUNDS	$106,645
2019	2019	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	675 HOES LN	PISCATAWAY	NJ	08854	MIDDLESEX	USA	Allergy and Infectious Diseases Research	003	4	6/13/2019	EXTENSION WITH OR WITHOUT FUNDS	$10,563
2019	2018	NEW YORK UNIVERSITY	550 1ST AVE	NEW YORK	NY	10016	NEW YORK	USA	Allergy and Infectious Diseases Research	000	3	2/22/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $366,946

Issue Date FY: 2018 ( Subtotal = $401,969 )
2018	2018	NEW YORK UNIVERSITY	550 1ST AVE	NEW YORK	NY	10016	NEW YORK	USA	Allergy and Infectious Diseases Research	000	3	3/19/2018	NON-COMPETING CONTINUATION	$401,969
														Subtotal = $401,969

Issue Date FY: 2017 ( Subtotal = $412,975 )
2017	2017	NEW YORK UNIVERSITY	550 1ST AVE	NEW YORK	NY	10016	NEW YORK	USA	Allergy and Infectious Diseases Research	000	2	3/23/2017	NON-COMPETING CONTINUATION	$412,975
														Subtotal = $412,975

Issue Date FY: 2016 ( Subtotal = $423,750 )
2016	2016	NEW YORK UNIVERSITY MEDICAL CENTER	550 1ST AVE, SC-2 KIPS BAY BG	NEW YORK	NY	10016	NEW YORK	USA	Allergy and Infectious Diseases Research	000	1	3/18/2016	NEW	$423,750
														Subtotal = $423,750

Grand Total All Awards = $5,144,091

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Microbial, immune, metabolic perturbations by antibiotics (MIME study)

Award Number: U01AI122285

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 05/01/2019

PERIOD OF PERFORMANCE END DATE: 12/31/2026

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