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Dosing and Pilot Efficacy of 2'-Fucosyllactose in Inflammatory Bowel Disease

Award Number: R01HD094862
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: 07/12/2018
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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Dosing and Pilot Efficacy of 2'-Fucosyllactose in Inflammatory Bowel Disease - Crohn’s Disease (CD) is a chronic and debilitating disorder with peak incidence in the second and third decades of life. While considerable progress has been made in optimizing medications to achieve remission, relapse is common and unpredictable. Altered microbiota likely drive gut inflammation and clinical relapses. Microbiota-accessible dietary carbohydrates with beneficial health effects, known as “prebiotics,” hold promise for restoring healthy gut microbiota in CD and preventing clinical relapse. Here, we propose completion of the first studies of the prebiotic human milk oligosaccharide, 2’-fucosyllactose (2’-FL), for maintaining remission in CD. Our overarching hypothesis is that 2’-FL supplementation in CD will be safe and well tolerated, while increasing fecal Bifidobacterium abundance and butyrate in a dose dependent manner. We will test this hypothesis by completing a randomized, placebo-controlled dose-ranging study which began enrollment during the tenure of the current award and includes the following Aims: Aim 1. Define dose dependent safety and tolerability of 2’-FL as a dietary supplement in CD. We will test 1g or 5g 2’-FL compared to 2 gm dextrose placebo as a daily dietary supplement in pediatric and young adult CD patients in stable remission receiving infliximab or adalimumab anti-TNF therapy. Safety and tolerability will be assessed using validated clinical disease activity and gastrointestinal symptom rating indices, and fecal calprotectin. Aim 2. Define dose dependent efficacy of 2’-FL as a dietary supplement in CD. We will utilize our established fecal metagenomic and metabolite profiling assays to test the effect of a range of 2’FL doses upon the gut microbial community and associated metabolic functions with a focus upon butyrate production. Efficacy will be assessed by determining the dose dependent effect of 2’-FL upon increased fecal Bifidobacterium and butyrate abundance. We will account for FUT2 secretor status and dietary fiber intake in the analysis. These studies will have a high impact in the field by providing critical phase I/IIa safety and efficacy data in support of a phase III RCT using our NIH-supported CD clinical research network to test the efficacy of 2’-FL in directly modulating beneficial microbiota and thereby enhancing sustained clinical remission and mucosal healing. Ultimately the proposed studies will promote a fundamental shift in clinical practice towards personalized microbial therapeutic 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 = $677,278 )
2025	2025	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	002	7	6/26/2025	NON-COMPETING CONTINUATION	$677,278
2025	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	001	6	2/18/2025	COMPETING CONTINUATION	$249,952
2025	2022	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	5	2/18/2025	NON-COMPETING CONTINUATION	-$249,952
														Subtotal = $677,278

Issue Date FY: 2024 ( Subtotal = $710,020 )
2024	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	002	6	7/18/2024	COMPETING CONTINUATION	$710,020
2024	2022	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	001	5	7/10/2024	NON-COMPETING CONTINUATION	$0
2024	2022	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	5	4/4/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $710,020

Issue Date FY: 2022 ( Subtotal = $467,323 )
2022	2022	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	002	5	7/6/2022	NON-COMPETING CONTINUATION	$0
2022	2022	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	001	5	4/22/2022	NON-COMPETING CONTINUATION	$467,323
2022	2021	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	4	11/24/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $467,323

Issue Date FY: 2021 ( Subtotal = $658,089 )
2021	2021	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	4	4/19/2021	NON-COMPETING CONTINUATION	$658,089
														Subtotal = $658,089

Issue Date FY: 2020 ( Subtotal = $666,974 )
2020	2020	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	3	3/26/2020	NON-COMPETING CONTINUATION	$666,974
														Subtotal = $666,974

Issue Date FY: 2019 ( Subtotal = $667,198 )
2019	2019	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	2	2/28/2019	NON-COMPETING CONTINUATION	$667,198
														Subtotal = $667,198

Issue Date FY: 2018 ( Subtotal = $485,411 )
2018	2018	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Child Health and Human Development Extramural Research	000	1	7/12/2018	NEW	$485,411
														Subtotal = $485,411

Grand Total All Awards = $4,332,293

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Dosing and Pilot Efficacy of 2'-Fucosyllactose in Inflammatory Bowel Disease

Award Number: R01HD094862

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: 07/12/2018

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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