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Lactoferrin and lysozyme to promote nutritional, clinical, and enteric recovery: A factorial placebo-controlled randomized trial among children with diarrhea and malnutrition

Award Number: R01HD103642
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/01/2021
PERIOD OF PERFORMANCE END DATE: 11/30/2025

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Lactoferrin and lysozyme to promote nutritional, clinical, and enteric recovery: A factorial placebo-controlled randomized trial among children with diarrhea and malnutrition - PROJECT SUMMARY/ABSTRACT Diarrhea kills more than half a million children each year and is the third largest contributor to lost disability adjusted life years. While rehydration addresses the acute consequences of diarrhea, there are no interventions for diarrhea convalescence during which children are at high risk of malnutrition, lower-respiratory tract infections, and recurring diarrhea episodes. Safe and effective interventions to address the long-term consequences of diarrheal disease are urgently needed. Lactoferrin and lysozyme are milk-derived nutritional supplements that may reduce the duration of diarrheal episodes, treat or prevent underlying enteric infections, improve enteric function, and accelerate nutritional recovery. However, it remains unclear whether their antimicrobial action will translate into significant improvements in the long-term clinical and nutritional outcomes of childhood diarrhea. We propose a factorial, double-blind, placebo-controlled, randomized trial to determine the efficacy and mechanisms of lactoferrin and lysozyme supplementation in minimizing the incidence of diarrhea and promoting nutritional recovery among children recovering from diarrhea and wasting. Kenyan children aged 6-24 months who have been discharged from an inpatient or outpatient hospital stay for diarrhea, and have a mid-upper arm circumference [MUAC] <12.5 cm will be randomized to 16-weeks of lactoferrin, lysozyme, a combination of the two, or placebo. This trial will provide much efficacy, mechanistic, and feasibility data from populations most likely to benefit from these interventions.


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 = $642,554 )
2025	2025	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Child Health and Human Development Extramural Research	002	5	4/15/2025	NON-COMPETING CONTINUATION	$64,254
2025	2025	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Child Health and Human Development Extramural Research	001	5	12/3/2024	NON-COMPETING CONTINUATION	$0
2025	2025	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Child Health and Human Development Extramural Research	000	5	12/2/2024	NON-COMPETING CONTINUATION	$578,300
														Subtotal = $642,554

Issue Date FY: 2024 ( Subtotal = $613,886 )
2024	2024	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Child Health and Human Development Extramural Research	001	4	5/2/2024	NON-COMPETING CONTINUATION	$55,809
2024	2024	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Child Health and Human Development Extramural Research	000	4	11/22/2023	NON-COMPETING CONTINUATION	$558,077
														Subtotal = $613,886

Issue Date FY: 2023 ( Subtotal = $551,936 )
2023	2023	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Child Health and Human Development Extramural Research	001	3	2/6/2023	NON-COMPETING CONTINUATION	$55,194
2023	2023	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Child Health and Human Development Extramural Research	000	3	11/8/2022	NON-COMPETING CONTINUATION	$496,742
														Subtotal = $551,936

Issue Date FY: 2022 ( Subtotal = $553,912 )
2022	2022	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Child Health and Human Development Extramural Research	001	2	12/2/2021	NON-COMPETING CONTINUATION	$498,520
2022	2022	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Child Health and Human Development Extramural Research	002	2	4/25/2022	NON-COMPETING CONTINUATION	$55,392
2022	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Child Health and Human Development Extramural Research	000	1	12/1/2021	NEW	$0
														Subtotal = $553,912

Issue Date FY: 2021 ( Subtotal = $670,887 )
2021	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Child Health and Human Development Extramural Research	000	1	12/28/2020	NEW	$670,887
														Subtotal = $670,887

Grand Total All Awards = $3,033,175

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Lactoferrin and lysozyme to promote nutritional, clinical, and enteric recovery: A factorial placebo-controlled randomized trial among children with diarrhea and malnutrition

Award Number: R01HD103642

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 01/01/2021

PERIOD OF PERFORMANCE END DATE: 11/30/2025

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