Gut Microbiome Pill

A Pilot Proof of Concept Study, Single-center, Open-label Study to Assess the Safety and Efficacy of an Ingestible Pill for Gut Microbiome Sampling in Healthy Humans

The purpose of this study is to evaluate the safety and efficacy of a 3D-printed ingestible pill designed to sample microbiota from the GI tract, focusing on the ability to collect data also from the small intestine. The study also aims to assess ease of use and transit time.

This is a prospective, open-label pilot study designed to evaluate the safety and efficacy of a 3D-printed ingestible pill for microbiome sampling throughout the gastrointestinal (GI) tract, with a specific advantage in being able to sample bacteria from the small intestine. The study will enroll 10 participants, each ingesting the pill. Participants will use a metal detection device to identify the pill in their stool. Upon detection, participants will collect the stool sample and send it to the lab, where the pill will be extracted. Both the pill and stool samples will undergo 16S rRNA sequencing to profile the microbiome. The study will take approximately 4 days per participant

Inclusion Criteria:

1. Healthy adults aged 18-65.
2. Willing and able to provide informed consent.
3. Able and willing to comply with study procedures, including pill ingestion, stool collection, follow and record dietary instructions, and fill questionnaires.

Exclusion Criteria:

1. History of gastrointestinal diseases (e.g., Crohn's disease, irritable bowel syndrome, small intestinal bacterial overgrowth).
2. History of abdominal surgery that may impact gastrointestinal function (e.g., bowel resection, bariatric surgery).
3. Known allergies or intolerances to medical devices or ingestible capsules.
4. Recent antibiotic use (within 3 months) that may affect gut microbiome results.
5. Use of medications that alter GI motility such as laxatives or prokinetics.
6. Known anatomical abnormalities or strictures in the GI tract that increase the risk of obstruction.
7. Pregnant, planning pregnancy or breastfeeding, since pregnancy and breastfeeding affect the microbiome, Exclusion of pregnancy will be confirmed by the date of the last menstrual period.
8. Participation in another investigational trial within the last 30 days.