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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18-
- •Willing and able to provide informed consent.
- •Able and willing to comply with study procedures, including pill ingestion, stool collection, follow and record dietary instructions, and fill questionnaires.
排除标准
- •History of gastrointestinal diseases (e.g., Crohn's disease, irritable bowel syndrome, small intestinal bacterial overgrowth).
- •History of abdominal surgery that may impact gastrointestinal function (e.g., bowel resection, bariatric surgery).
- •Known allergies or intolerances to medical devices or ingestible capsules.
- •Recent antibiotic use (within 3 months) that may affect gut microbiome results.
- •Use of medications that alter GI motility such as laxatives or prokinetics.
- •Known anatomical abnormalities or strictures in the GI tract that increase the risk of obstruction.
- •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.
- •Participation in another investigational trial within the last 30 days.
研究组 & 干预措施
Microbiome sampling
Participants will ingest one single 3D-printed pill and monitor for the pill in their stool over the next 4 days using a metal detection device. Upon detection participants will collect a sample of the stool and the pill.
干预措施: 3D-printed ingestible pill (Device)
结局指标
主要结局
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
时间窗: 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
时间窗: 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.
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
时间窗: 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
时间窗: 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.
次要结局
- Time taken for the pill to pass through the GI tract(From ingestion until pill retrieval (up to 4 days))