Assessing Changes in the Gut Microbiome of Non-Gastrointestinal Disordered Subjects Before and After Oral Prebiotic Supplementation Using the SIMBA Capsule
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-group clinical study. The primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of healthy participants without any known gastrointestinal disorders from baseline to endpoint in response to the prebiotic intervention (FiberSmart). The study population are adults (n=30) who will ingest either the FiberSmart or a matched Placebo daily for 21 days. Both products will be referred to as the Investigational Product (IP) in the study procedures section. While prebiotics are widely used for gut health, their specific impact on the small intestinal ecosystem remains largely uncharacterized compared to the large intestine. Understanding their impact on the upper GI tract can lead to new insights into their mechanisms of action. Given the critical role of the small intestine in metabolism and immunity, the study utilizes the SIMBA capsule to measure novel changes in the small intestine along with traditional measurements from stool samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged 19-40 years old at the inclusion of the study, both female and male subjects.
- •Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit.
- •Willing to maintain their current lifestyle during the study.
- •Able to swallow a 25mm length and 9mm width sized capsule.
- •At least a four-week washout period between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study.
- •Signed Informed Consent, and willing to follow the study procedures, including consumption of study product per the protocol and completing any forms/questionnaires needed throughout the study.
排除标准
- •Use of any prescription medication within 14 days prior to the start of the study, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant (excluding oral contraceptives).
- •Any current acute or chronic medical condition, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant.
- •Known or suspected history of any gastrointestinal disease including, but not limited to, irritable bowel syndrome, celiac disease (treated or untreated), inflammatory bowel disease, persistent diarrhea, chronic constipation, gastrointestinal malignancy, or any condition known to affect gastrointestinal motility or absorption.
- •Less than 3 bowel movements a week
- •If using Proton Pump Inhibitors (PPIs), unable to stop for PPIs 24hrs prior to SIMBA capsule ingestion and 4 hours after
- •Prior gastrointestinal surgery, or radiation treatment which, in the Investigator's opinion, may lead to intestinal stricturing or obstruction with a risk of capsule non-excretion, including, e.g., untreated achalasia, eosinophilic esophagitis, cancer diagnosis (depending on timing, location, and treatment) or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.
- •History of known structural gastrointestinal abnormalities such as strictures or fistulas leading to mechanical obstruction.
- •Organic motility disorder (e.g., gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome) with a history of swallowing difficulty or oropharyngeal dysphagia.
- •Use of metformin within 3 months prior to the start of the study
- •Use of any oral or intravenous antibiotics within 3 months prior to the baseline study timepoint (topical antibiotics are acceptable).
- •Use of probiotics, prebiotics, fibre (Metamucil, FibreOne, etc.) or any other supplements known to affect the gastrointestinal microbiota within 14 days prior to the baseline study timepoint.
- •Known or suspected allergy or intolerance to the IP or its components.
- •Pregnant or breastfeeding women.
- •Excessive alcohol consumption or drug abuse.
研究组 & 干预措施
Prebiotic
干预措施: FiberSmart (Dietary Supplement)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Primary
时间窗: Baseline (day 0) to the end of Intervention (day 21)
To evaluate changes in the small intestinal microbiome of healthy participants from baseline to the end of the 21-day FiberSmart intervention, as assessed by differential abundance testing of bacterial taxa across sampling timepoints using the SIMBA capsule. Shotgun metagenomic sequencing will be used to characterize taxonomic and functional shifts in the small intestinal microbiome.
次要结局
- Secondary 1(Baseline (day 0) to the end of Intervention (day 21))
- Secondary 2(Baseline (day 0) to the end of Intervention (day 21))
- Secondary 3(Baseline (day 0) to the end of Intervention (day 21))