20 Sep 2024 — Probiotics R&D company Lallemand Health Solutions will conduct a clinical trial to assess the efficacy of the Bacillus subtilis R0179 strain in alleviating symptoms of Small Intestinal Bacterial Overgrowth (SIBO) in collaboration with Nimble Science, a small intestine sampling technology expert, using its new SIMBA Capsule.
“Though gut health is considered a mature market, it remains the primary area of research for probiotics. Various regions of the gastrointestinal tract are still understudied due to limited access, leading to unsatisfactory characterization and support for gastrointestinal disorders,” Sylvie Binda, VP of R&D at Lallemand Health Solutions, tells Nutrition Insight.
“For example, SIBO presents a significant diagnostic and therapeutic challenge in gastroenterology, often marked by delayed or incorrect diagnosis. As pioneers in probiotic research, we aim to develop innovative solutions for human health and a better quality of life. Focusing on the small intestine is one of our key R&D pillars.”
Dr. Joseph Wang, chief technology officer at Nimble Science, explains: “The SIMBA capsule is a single-use, ingestible capsule designed to collect, seal and preserve luminal samples directly from the small intestine, the primary site for nutrient absorption and is critical in the etiology of many gut disorders and disease. Unlike stool sampling, the SIMBA capsule captures a small intestinal multi-omic sample with spatial and temporal precision to better delineate the host-food-microbiome interactions deep in the gut.”
Binda adds: “We are proud to reinforce our long-time collaboration with Nimble Science. Lallemand Health Solutions recognized and anticipated the potential of the SIMBA capsule from its early stages. We are enthusiastic about the potential outcomes of this new project.”
Novel SIBO research
Wang tells us that the small intestinal microbiome’s composition and its interaction with probiotics are still poorly understood due to the lack of access. “This study aims to identify the characteristic composition of the small intestinal microbiome in SIBO patients and to evaluate the long-term impacts of the probiotic Bacillus subtilis R0179 on the small intestinal microbiome and the associated gastrointestinal (GI) symptoms.
Binda says that “Bacillus subtilis R0179 was naturally selected for its robustness and extensive documentation in various GI applications.”
“Previous research has shown that this probiotic strain has the potential to improve quality of life and SIBO symptoms. This study aims to demonstrate the direct impacts of this probiotic strain on the microbiome and metabolome levels of the small intestine.”
Wang and his team hope that the study will demonstrate the long-term impact of probiotics on gut microbiome in the upper GI tract, “which may have been underplayed in studies that rely on stool alone, can be assessed using our novel technology.”
“These findings will advance our understanding of SIBO and pave the way for a novel microbiome-based therapeutic strategy for SIBO and other disease areas as well.”
The SIMBA capsule
The research is made possible by the development of the SIMBA capsule by Nimble. Wang details: “The SIMBA GI Platform has been fully validated to collect a repeatable preserved luminal sample for metagenomic and metabolomic sequencing directly from the ileum or jejunum region without contamination from the colon.”
“The system is in use in multiple clinical studies all around the world to evaluate the impact of various types of products and to elucidate the small intestinal microenvironment with various diseases,” he continues.
“The challenge is the lack of genomic and metabolomic data sets available on the microenvironment of the small intestine, especially among the healthy population. Nimble collaborates with our partners to help build the data set needed to really advance the insights that come from the SIMBA capsule.”
Binda notes that endoscopy is currently the gold standard test for assessing bacterial overgrowth. “However, this method is costly, not systematically offered and represents a significant burden for healthcare systems, patients and study participants.”
“In contrast, the SIMBA capsule is a single-use, ingestible passive capsule that allows for non-invasive sampling of small intestinal contents. Its ease of administration and actionable health data insights could represent a significant advancement in the research, diagnosis and treatment of SIBO and other GI conditions.”
Wang adds to Binda’s point: “A growing body of evidence suggests the limitations of fecal sampling. On the other hand, direct endoscopic sampling of the GI tract is invasive and expensive. In fact, Nimble and Lallemand previously conducted a successful proof-of-principle study to demonstrate the efficacy of Nimble’s SIMBA capsule in real-time collection of a single dose of probiotic from the small intestine.”
“The clinical study results were recently published in the scientific journal Frontiers in Microbiomes. This successful demonstration has provided confidence for the two companies to continue their collaboration and launch a new study to track the effects of long-term probiotic intervention.”
The clinical trial
Binda tells us more about the SIBO double-blind, randomized, placebo-controlled clinical study as well as about Lallemand’s goals and ambitions.
“The study involves several key opinion leaders and expert investigators in gastroenterology. Recruitment is ongoing, with a target of 105 participants. Preliminary results are expected next year,” she details.
“This study aligns perfectly with Lallemand’s current research program on the microbiome. Our objective is to adequately collect and characterize the microbiome of various body areas to develop targeted probiotic solutions. We aim to assess the mechanisms behind their potential abilities to modulate these microbiomes.”
Wang states that the trial is of “great importance” to Nimble as well as “it will extend our knowledge of the difference in the small intestinal microbiome in SIBO, and will further support the development of some of the first clinical tools to help better assess this condition.”
“We’ll work closely with Lallemand Health Solutions and our clinical partners to collect and analyze data as the trial progresses. The good news is that our ongoing recruitment of subjects is across Canada, facilitated by the trial’s remote design. Participants can conveniently ingest SIMBA capsules from the comfort of their homes.”
Future research
The findings from this study will likely impact other areas of GI research beyond SIBO, according to Wang. “Nimble Science has already initiated a series of observational studies to characterize the small intestinal microbiome in various disease areas, including those beyond the GI field.”
“The significance of this study is that it is the first time we have an interventional design utilizing the SIMBA capsule being applied to investigate the effects of long-term biotic foods (prebiotics, probiotics, postbiotics) or live biotherapeutics on the small intestinal microbiome in a wide range of diseases. These findings could potentially lead to new therapeutic development strategies and personalized treatments for various GI disorders.”
He points out that in recent years, scientists have increasingly discovered the various impacts of the gut microbiome on human health and diet.
“By directly sampling the small intestinal contents using the SIMBA capsule coupled with fecal sampling, this new study could catalyze a paradigm shift in gut microbiome-based research. We can depict a more complete picture of the gut microbiome’s distribution and function by integrating longitudinal data obtained from fecal samples and SIMBA capsules.”
By Milana Nikolova