Notice of Special Interest: Development of Swallowable Smart Pills or Devices for Precision Nutrition, Microbiome and Digestive Disease Applications

Notice Number: NOT-DK-20-001

Key Dates
Release Date: November 1, 2019
First Available Due Date: January 05, 2020
Expiration Date: January 08, 2023

Related Announcements

PA-19-270 - Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PA-19-272 - PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

PA-19-273 - PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

NOT-DK-19-020 - Request for Information (RFI): Swallowable Smart Pills or Devices to Enable Precision Nutrition, Microbiome and Gastroenterological Research

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

The purpose of this Notice is to inform potential applicants of an area of special interest in developing swallowable smart pills or devices to advance precision nutrition, microbiome and gastroenterological research.

Background

Many anatomical regions of the gastrointestinal tract—where digestion and absorption occur, where nutrient and metabolic signals operate, and where discrete microbiome ecologies exist and influence host biology—are beyond the reach of modern endoscopy and therefore difficult to study, challenge, or sample, especially for large epidemiological studies where multiple and repeated sampling is needed. The host-microbial interactions and metabolic processes that occur in some of these discrete anatomical regions are thought to play a key role in tastant, incretin, and vagovagal signaling; gastrointestinal (GI) reflexes (e.g., through gut-brain axis or enteroendocrine responses); and inflammation of the gastrointestinal-associated lymphoid tissues. That suggests a need for better understanding of regional diet-GI physiology and diet-microbiome relationships. Even for GI regions that are accessible to endoscopy, the required preparation and conduct of current procedures (e.g., fasting, bowel prep, and anesthesia) significantly disrupt normal physiology of the GI tract and microbiota ecology, precluding the study of diet interrelationships, microbiota ecology, metabolism, and signaling in situ. Thus, a significant challenge for investigators is the limited resources for exploration of regional ecologies and biology along the full length of the GI tract. Developing these technologies so that they are more accessible for clinical research will allow capturing critical data elements for enhancing knowledge of diet-gastrointestinal biology and diet-microbiota-host interrelationships.

NIDDK Statement of Interest

Applications responsive to this NOSI will propose to develop and test in appropriate models/patients a prototype smart pills that will enable examination of regional digestion, absorption, metabolism, mucosal interactions and/or microbial ecologies in awake and fed humans.

Some of these technologies may facilitate visualization, sensing, biopsy, and sample delivery or collection within discrete regions of the GI tract. Such tools could possibly allow sampling at a single time point or repeated measures or support activities performed for short periods of time, e.g., post-prandially. Additionally, developmental research may be needed to advance other desired applications (e.g., non-invasive collection of material that stabilize metabolites, DNA, or RNA using laser capture microfluidic methodologies or other strategies for culturomics). Our goal is to commercialize these tools for clinical research and clinical care.

Application and Submission Information

This notice applies to due dates on or after January 5, 2020 and subsequent receipt dates through January 8, 2023.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

Activity Code

FOA

First Available Due Date

R43/R44

PA-19-272: PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

January 5, 2020

R41/R42

PA-19-270: PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

January 5, 2020

R43/R44

PA-19-273: PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

January 5, 2020

 

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

  • For funding consideration, applicants must include “NOT-DK-20-001” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with the program officer listed on this NOSI in advance of the grant receipt date.

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.

 

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Christopher J. Lynch, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases, Office of Nutrition Research
Telephone: 301-827-3988
Email: christopher.lynch@nih.gov