Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT07220369
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:
NCT07220369
Study Brief:
Protocol Section:
NCT07220369