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Ingestible Pill for spatially targeted sampling of gut microbiome

Award Number: R33DK132314
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/13/2022
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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Ingestible Pill for spatially targeted sampling of gut microbiome - Project Summary This R21/R33 proposal is submitted in response to PAR-20-133. The proposal focuses on the development of an ingestible device termed “micro-pill”. The micro-pill will be designed to autonomously sample intestinal content from predetermined anatomical sites in the gastrointestinal (GI) tract, a process which currently requires invasive methods. The development of the micro-pill benefits from the applicants' experimentation with an earlier version of the pill that utilizes an osmotic pump for sampling. To ensure accurate sampling of GI luminal content from specific anatomical sites, the micro-pill will be fitted with a miniaturized motor controlled by pH and pO2 sensors. The concept takes advantage of the proximal-to-distal rising pH and falling oxygen gradient, such that the micro-pill will sample autonomously based on pre-programmed pH and O2 thresholds. This innovative control mechanism is optimal for this application because it dispenses with the need for tomography or built-in camera that may be needed to track the pill's location for spatially selective sampling. The new micro-pill will run on power from a coin cell battery and will also support wireless magnetic activation in individuals where pH/pO2 levels may be altered due to atypical GI tract conditions. The architecture of the micro-pill is optimized to enable sampling of viscous intestinal content and reduce leakage and contamination, while maximizing the volume of sample collected and maintaining low specific weight for improved buoyancy and motility through the GI tract. During the R21 phase micro-pill prototypes will be built and tested in vitro in conditions simulating the viscosity of the GI lumen and ex vivo in pig intestines. Optimized designs will be tested in live pigs. The R21 phase is organized in 3 specific aims: (1), To design, fabricate and validate in vitro a motorized micro-pill; (2) To design, integrate and test pH/pO2 sensors in vitro and ex vivo using electronics integrated in the micro-pill; (3) To test the ingestible micro-pill in live pigs in vivo. The aims of the R33 phase are to assess the efficacy of the micro- pill (4) and conducting a 2-phase randomized controlled cross-over diet trial in humans (5). In Specific aim 4 the feasibility of sampling human adults' luminal content from pre-determined GI tract regions will be tested in a clinical trial. The trial will not only assess the micro-pill's function, but also compare the effects of a plant-based and a meat-based diet on the GI tract microbiota collected from different anatomical GI sites. This proposal was conceived by three Tufts University researchers with complementary expertise. PI Dr. Sameer Sonkusale from the School of Engineering heads an interdisciplinary Nano Lab and specializes in micro- and nano-fabrication, and biomedical devices. Dr. Giovanni Widmer from the School of Veterinary Medicine has extensive experience with animal models, microbiota analysis and bioinformatics. Dr. Alice H Lichtenstein at the Jean Mayer USDA Human Nutrition Research Center for Aging brings to the project years of experience with diet-related human intervention trials.


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 = $768,139 )
2025	2025	TRUSTEES OF TUFTS COLLEGE	80 GEORGE ST	MEDFORD	MA	02155	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	7/11/2025	NON-COMPETING CONTINUATION	$689,725
2025	2024	TRUSTEES OF TUFTS COLLEGE	169 HOLLAND ST	SOMERVILLE	MA	02144	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	10/16/2024	EXTENSION WITH OR WITHOUT FUNDS	$78,414
														Subtotal = $768,139

Issue Date FY: 2024 ( Subtotal = $775,340 )
2024	2024	TRUSTEES OF TUFTS COLLEGE	169 HOLLAND ST	SOMERVILLE	MA	02144	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	8/12/2024	EXTENSION WITH OR WITHOUT FUNDS	$775,340
														Subtotal = $775,340

Grand Total All Awards = $1,543,479

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Ingestible Pill for spatially targeted sampling of gut microbiome

Award Number: R33DK132314

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/13/2022

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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