Notice Number: NOT-DK-19-020

Key Dates
Release Date: July 25, 2019
Response Date: September 30, 2019

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

Purpose

The purpose of this Request for Information (RFI) is to solicit public input to inform efforts aimed at advancing the development of and accessibility to devices that enable clinical gastroenterological procedures on awake individuals and research on dietary components-host interactions and gut microbiota ecology in discrete gastrointestinal (GI) regions, with the focus on advancing host-diet microbial interactions.

The information respondents provide will help characterize what technologies are currently available to facilitate the study of discrete regions of the human GI tract as well as identify key priorities and recommendations for future research efforts.

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; 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.

Tools that enable examination of regional digestion, absorption, metabolism, mucosal interactions and microbial ecologies in awake and fed humans are under development but not yet widely available for biomedical researchers. Some of these technologies may facilitate visualization, sensoring, biopsy, and sample delivery or collection within discrete regions of the GI tract (e.g., smart pills). 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. Developing these technologies so that they are more accessible for clinical research will allow capturing critical data elements for enhancing knowledge of diet-gastrointestinal and diet-microbiota-host interrelationships. 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). Such advances could enhance discovery or hypothesis-based research applications in clinical trials or clinical research, and/or patient care.

Information Requested

This RFI seeks input from knowledgeable individuals and stakeholders throughout the scientific research and bioengineering community and the public regarding any of the following topics:

• Awareness of any swallowable, micro-robotic tools that can be used to facilitate visualization, localization, biopsies, sample collection, or sample delivery to multiple locations in the GI tract in humans (in a fed and awake state) and knowledge of any tools that are in development.
• Technologies or applications that need to be further developed in order to advance the use of tools to sample multiple, discreet regions of the GI tract.
• Challenges that need to be overcome to advance the accessibility of these tools.
• Specific capabilities that should be prioritized in a device that could be used to study diet-microbiota-host interactions along discrete regions of the GI tract and why they should be prioritized.

How to Submit a Response

Responses to this RFI must be submitted electronically to [email protected].

Responses must be received by 11:59 p.m. on September 30, 2019.

Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

NIH looks forward to your input and we hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to:

Christopher Lynch, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-3988
Email: [email protected]