Tuesday, September 16, 2025 9/16/2025

Trial of Human Milk Oligosaccharide-based synbiotics for HIV-exposed uninfected children

Award Number: R01HD105492
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: 06/01/2021
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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Trial of Human Milk Oligosaccharide-based synbiotics for HIV-exposed uninfected children - Project Summary HIV-exposed uninfected (HEU) infants have higher rates of mortality, infectious morbidity and growth deficits compared to HIV-unexposed uninfected (HUU) infants despite the success of maternal antiretroviral therapy (ART) in reducing vertical transmission. Our group has observed that human milk oligosaccharide (HMO) composition of breastmilk, and its relationships to the infant gut microbiome maturity and composition, may account for some of the increased risks seen in HEU infants. Currently, no specific interventions have been shown to correct for disparities in health outcomes experienced by HEU infants. To address this gap, we propose a proof-of-concept, randomized, placebo-controlled trial of a synbiotic in breast-fed HEU infants. The synbiotic is composed of 2'-fucosyllactose (2'FL) HMO and B. infantis probiotic. 2'FL is associated with reductions in mortality, infectious morbidity and growth deficits. B. infantis is included to support 2'FL fermentation and thereby maximize benefits from the 2'FL intervention. We will randomize 120 breast-fed HEU infants at 4 weeks of age 1:1 to receive synbiotic or placebo through 24 weeks of age, with a follow-up through 48 weeks of age. We will also recruit 60 breast-fed HUU infants as a comparator group and they will be followed for the same duration with no intervention. This study will be conducted in rural South Africa, in a region with high maternal HIV prevalence and high rates of infectious morbidity and growth deficits in infants. In specific aim 1, we will evaluate whether the synbiotic i) reduces infectious morbidity and growth faltering, and ii) influences biological pathways related to infant gut microbiome, metabolism, and inflammation while the intervention is in place during the first 24 weeks of age. In specific aim 2, we will evaluate whether effects persist after the intervention is discontinued through 48 weeks of age. Specific aim 3 will compare HEU and HUU cohorts and investigate biological pathways associated with infectious morbidity and growth. Overall, we hypothesize that the synbiotic will reduce infectious morbidity and improve growth in HEU infants. Our study will provide novel information on whether some of the excess risks in HEU infants can be ameliorated through interventions targeting breastfeeding-mediated microbiome and inflammatory pathways.


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 = $757,348 )
2025	2025	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Child Health and Human Development Extramural Research	002	5	8/19/2025	NON-COMPETING CONTINUATION	$757,348
2025	2024	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Child Health and Human Development Extramural Research	001	4	7/9/2025	NON-COMPETING CONTINUATION	$0
2025	2024	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Child Health and Human Development Extramural Research	000	4	3/14/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $757,348

Issue Date FY: 2024 ( Subtotal = $732,299 )
2024	2024	THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Child Health and Human Development Extramural Research	000	4	6/21/2024	NON-COMPETING CONTINUATION	$732,299
														Subtotal = $732,299

Issue Date FY: 2023 ( Subtotal = $1,065,574 )
2023	2023	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Child Health and Human Development Extramural Research	002	3	6/5/2023	NON-COMPETING CONTINUATION	$713,526
2023	2023	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Child Health and Human Development Extramural Research	001	2	1/12/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2023	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Child Health and Human Development Extramural Research	000	2	1/6/2023	SUPPLEMENT FOR EXPANSION	$352,048
														Subtotal = $1,065,574

Issue Date FY: 2022 ( Subtotal = $643,360 )
2022	2022	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Child Health and Human Development Extramural Research	001	2	7/25/2022	NON-COMPETING CONTINUATION	$643,360
2022	2021	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Child Health and Human Development Extramural Research	000	1	1/6/2022	NEW	$0
														Subtotal = $643,360

Issue Date FY: 2021 ( Subtotal = $700,756 )
2021	2021	TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, THE	630 W 168TH ST FL 4	NEW YORK	NY	10032	NEW YORK	USA	Child Health and Human Development Extramural Research	000	1	5/31/2021	NEW	$700,756
														Subtotal = $700,756

Grand Total All Awards = $3,899,337

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Trial of Human Milk Oligosaccharide-based synbiotics for HIV-exposed uninfected children

Award Number: R01HD105492

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: 06/01/2021

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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