Healthy
Conditions
Keywords
microbiome, microbiota, microbiome sampling pill
Brief summary
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.
Detailed description
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
Interventions
DEVICE3D-printed ingestible pill
The pill consists of a microporous architecture specifically designed to trap bacteria. The pill contains a ferrous (iron) ball for detection with a metal detection device and passes naturally and passively through the GI tract.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who successfully passed the pill through the GI tract without causing any adverse effects such as GI discomfort, obstruction, or other complications | Pill retrieval (up to 4 days) | Participants will be asked to report any subsequent events to the study team. Adverse Events (AEs) will be collected through solicited questions (e.g., "Have you experienced any discomfort after ingesting the pill?") and unsolicited reports from participants. All events will be categorized, and severity will be graded. |
| Number of samples that accurately represents bacterial populations in the small intestine, as well as the entire GI tract, when compared to stool samples | Pill retrieval (up to 4 days) | Outcome is evaluated using 16S ribosomal RNA (rRNA) sequencing to compare microbial diversity and the presence of specific bacterial taxa between the pill and stool samples. |
Secondary
| Measure | Time frame |
|---|---|
| Time taken for the pill to pass through the GI tract | From ingestion until pill retrieval (up to 4 days) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSeth Gross, MD
NYU Langone Health
Outcome results
None listed