Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT07220369
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2025-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gut Mini-Pill Study
Sponsor:
Tufts University
Organization:
Study Overview
Official Title:
Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this proof-of-concept study in humans is to determine if a noninvasive, ingestible device, called a "mini-pill", can collect gastrointestinal (GI) luminal content samples from 2 different locations along the GI tract after consumption of diets differing in protein source (meat and plant-based meat alternatives). The mini-pills will be recovered in the stool. We will analyze the microbial profile of the mini-pill contents and in stool, and also measure blood biomarkers related to cardiometabolic risk, to better understand the relationship between diet, microbiota and health.
Detailed Description:
The ingestible mini-pill is a non-invasive, single-use, passive collection device that is not intended for diagnosis or treatment. The mini-pills have already been developed, tested and validated by two Tufts researchers, Drs. Sameer Sonkusale (School of Engineering) and Giovanni Widmer (School of Veterinary Medicine), in vitro, ex vitro, and in vivo in animal models (Supplement 1: Research Strategy and Supplement 2: Soft Autonomous Ingestible Device for Sampling the Small Intestinal Microbiome, Del-Rio-Ruiz R et al., manuscript in review). A NSR device designation is being sought from the IRB to conduct a 2-phase randomized-controlled double blind crossover trial in humans by providing two entrées per day containing either meat or plant-based meat alternatives for up to 3 weeks each. After 2 weeks on each diet, participants will consume a provided breakfast meal and then be asked to swallow 6 mini-pills along with a blue food coloring dissolved in 50 mL of water, return home and collect stool samples until all the mini-pills are recovered (varies between 2 and 4 days, but can be up to 6 days). This protocol will allow us to describe the diet-induced progressive change in the GI tract microbiota prior to and including that in the stool.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: