Few minimally invasive options for sampling the small intestinal (SI) luminal fluid exist to study the SI microbiota in health and disease. To address the lack of tools and methods to study GI regions that are difficult to access, Nimble Science developed a fully autonomous and passive sampling method, the Small Intestine MicroBiome Aspiration (SIMBA^TM) capsule, for convenient, high-quality, and reliable sampling to study the diet-microbiota interactions in the SI. The sealing efficacy and microbial DNA preservation capacity of the SIMBA capsules was first validated through in vitro simulation assays. Then, a clinical study was conducted with 20 healthy participants to validate the in vivo use of SIMBA capsules to reliably capture samples for SI microbiome analysis before and after an intervention (NCT04489329). Briefly, participants ingested the capsules at baseline and 7 days later, with a probiotic capsule containing a blend of L. rhamnosus R0011 and B. longum R0175. Following baseline SIMBA capsule ingestion, multiple low-dosage x-ray scans were performed to track the sampling location. Fecal samples corresponding with the baseline and intervention capsule were analyzed for comparison. The SIMBA capsules’ performance in vitro demonstrated the potential for contamination-free sampling with preservation of the microbial communities. Within the clinical study, the capsules performed safely and reliably for collection of SI content. X-ray tracking confirmed that 97.2% of the capsules completed sample collection in the SI regions before reaching the colon. Importantly, our data showed that the capsules sampled in the right area of the intestines and that baseline SIMBA microbiome profile is significantly different from fecal microbiome profile. SIMBA successfully detected a concurrent probiotic intervention in the small intestine, which was not detectable using stool samples. The high accuracy of sampling location and sealing efficacy of the SIMBA capsules makes them potentially useful research tools in clinical trials for studying diet-microbiota interactions in health and disease, and perhaps eventually for the clinical diagnosis of GI tract conditions affecting the SI such as SIBO.

中文翻译：

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使用具有 X 射线跟踪功能的 SIMBA Capsule 对小肠进行空间和时间上精确的微生物组分析

很少有微创方法可以对小肠 (SI) 腔液进行采样来研究健康和疾病中的 SI 微生物群。为了解决缺乏工具和方法来研究难以进入的胃肠道区域的问题，Nimble Science 开发了一种完全自主的被动采样方法，即小肠微生物抽吸 (SIMBA ^TM ) 胶囊，可实现方便、高质量和可靠的采样研究 SI 中饮食与微生物群的相互作用。 SIMBA 胶囊的密封功效和微生物 DNA 保存能力首先通过体外模拟测定得到验证。然后，对 20 名健康参与者进行了一项临床研究，以验证SIMBA 胶囊在干预前后可靠地捕获样本进行 SI 微生物组分析的体内使用 (NCT04489329)。简而言之，参与者在基线和 7 天后服用含有鼠李糖乳杆菌R0011 和长双歧杆菌R0175混合物的益生菌胶囊。在基线 SIMBA 胶囊摄入后，进行多次低剂量 X 射线扫描以跟踪采样位置。分析与基线和干预胶囊相对应的粪便样本以进行比较。 SIMBA 胶囊的体外性能证明了在保存微生物群落的情况下进行无污染采样的潜力。在临床研究中，胶囊在收集 SI 内容方面表现得安全可靠。 X 射线跟踪证实，97.2% 的胶囊在到达结肠之前完成了 SI 区域的样本采集。重要的是，我们的数据表明，在肠道右侧区域取样的胶囊以及基线 SIMBA 微生物组谱与粪便微生物组谱显着不同。 SIMBA 成功检测到益生菌对小肠的同时干预，这是使用粪便样本无法检测到的。 SIMBA 胶囊采样位置的高精度和密封功效使其成为临床试验中潜在有用的研究工具，用于研究健康和疾病中的饮食-微生物群相互作用，并可能最终用于影响 SI 的胃肠道状况（例如 SIBO）的临床诊断。