Thursday, February 19, 2026 2/19/2026

Fecal Microbiota Transplant National Registry

Award Number: R24AI118629
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/04/2016
PERIOD OF PERFORMANCE END DATE: 04/30/2027

Group Awards By:

View Award Description

Fecal Microbiota Transplant National Registry - PROJECT SUMMARY Fecal microbiota transplantation (FMT) is an established treatment for patients with recurrent Clostridioides difficile infection (CDI). Although most patients with CDI can be successfully treated, the subset of acutely ill patients with severe and fulminant CDI is a much greater challenge, with high rates of colectomy and mortality. Furthermore, a variety of safety concerns remain for FMT. The risk of transmission of harmful microbes is highlighted by recent reports of transmission of multi-drug resistant organisms and enteropathogenic E. coli (EPEC). In addition, although most work has focused on bacteria, FMT also transfers non-bacterial microorganisms, and the clinical impact of these microbes may be important in fully understanding the clinical implications of FMT. Because the gut microbiota also plays a role in the pathogenesis of chronic medical conditions (e.g., diabetes, cancer, heart disease), FMT has the potential to cause chronic conditions that might take years to manifest clinically. Finally, the field is rapidly evolving with the development of commercial products formulated with live microorganisms, known as live biotherapeutic products (LBPs). Thus, critically important questions regarding the real-world safety and effectiveness of FMT and LBPs remain unanswered. The FMT National Registry is a uniquely suited resource to study these key issues. The Registry includes 32 North American sites (and 19 additional centers pending) with an established infrastructure to collect clinical data on FMT donors and recipients and a separate portal to collect information from FMT recipients. The Registry’s link to an independent biobank also provides a rich source for studying manipulation of the gut microbiota in humans. Our first specific aim is to expand knowledge on the long-term safety and effectiveness of FMT by A) continuing systematic collection of clinical metadata up to 10 years post-FMT to better define safety, including risk of developing chronic medical conditions, with incidence rates for predefined chronic conditions in Registry participants compared with a control group of patients from a national database with multiply recurrent CDI not treated with FMT; B) determining real-world estimates of effectiveness of FMT and LBPs to treat hospitalized patients with severe/fulminant CDI and identify factors associated with cure; and C) expanding the registry to include new LBPs, assessing effectiveness for CDI as compared to FMT in real-world populations and examining off-label use of LBPs for indications beyond CDI. The second specific aim is to characterize the potential value of shotgun metagenomics sequencing (SMS) and data analytics as a platform technology to identify and characterize potentially harmful microbes transmitted by FMT or LBPs by first determining the sensitivity and specificity of SMS to identify and characterize bacterial pathogens using the emerging pathogen, atypical EPEC (aEPEC) as a prototype. Genotype-phenotype analyses will be performed using a combination of in vitro bioassays and whole genome sequencing. The sensitivity and specificity of SMS to identify these strains and their virulence genes will then be determined by fecal spiking experiments. Additionally, studies will be performed to characterize the impact of FMT/LBP therapy on the resistome and transmission of non-bacterial microbes (virome, mycobiome) with SMS in patients treated for severe/fulminant CDI.


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 = $672,796 )
2025	2025	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC	4930 DEL RAY AVE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	9	8/15/2025	NON-COMPETING CONTINUATION	$672,796
														Subtotal = $672,796

Issue Date FY: 2024 ( Subtotal = $673,041 )
2024	2024	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC	4930 DEL RAY AVE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	8	9/9/2024	NON-COMPETING CONTINUATION	$0
2024	2024	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC	4930 DEL RAY AVE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	8	4/23/2024	NON-COMPETING CONTINUATION	$673,041
														Subtotal = $673,041

Issue Date FY: 2023 ( Subtotal = $676,005 )
2023	2023	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC.	4930 DEL RAY AVENUE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	7	4/20/2023	NON-COMPETING CONTINUATION	$676,005
2023	2022	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC.	4930 DEL RAY AVENUE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	002	6	8/30/2023	COMPETING CONTINUATION	$542,299
2023	2020	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC.	4930 DEL RAY AVENUE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	5	8/30/2023	NON-COMPETING CONTINUATION	-$542,299
														Subtotal = $676,005

Issue Date FY: 2022 ( Subtotal = $684,035 )
2022	2022	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC.	4930 DEL RAY AVENUE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	6	5/16/2022	COMPETING CONTINUATION	$684,035
														Subtotal = $684,035

Issue Date FY: 2020 ( Subtotal = $701,629 )
2020	2020	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC.	4930 DEL RAY AVENUE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	5	7/10/2020	NON-COMPETING CONTINUATION	$701,629
														Subtotal = $701,629

Issue Date FY: 2019 ( Subtotal = $601,165 )
2019	2019	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC.	4930 DEL RAY AVENUE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	4	7/22/2019	NON-COMPETING CONTINUATION	$601,165
														Subtotal = $601,165

Issue Date FY: 2018 ( Subtotal = $941,794 )
2018	2018	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC.	4930 DEL RAY AVENUE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	3	8/23/2018	NON-COMPETING CONTINUATION	$288,069
2018	2018	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC.	4930 DEL RAY AVENUE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	3	7/26/2018	NON-COMPETING CONTINUATION	$653,725
														Subtotal = $941,794

Issue Date FY: 2017 ( Subtotal = $739,675 )
2017	2017	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC.	4930 DEL RAY AVENUE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	2	7/31/2017	NON-COMPETING CONTINUATION	$614,747
2017	2016	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE, INC.	4930 DEL RAY AVENUE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	12/2/2016	NEW	$124,928
														Subtotal = $739,675

Issue Date FY: 2016 ( Subtotal = $593,080 )
2016	2016	AMERICAN GASTROENTEROLOGICAL ASSOCIATION INSTITUTE INC	4930 DEL RAY AVENUE	BETHESDA	MD	20814	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	8/4/2016	NEW	$593,080
														Subtotal = $593,080

Grand Total All Awards = $6,283,220

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Fecal Microbiota Transplant National Registry

Award Number: R24AI118629

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/04/2016

PERIOD OF PERFORMANCE END DATE: 04/30/2027

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer