Lallemand Health Solutions Launches a Groundbreaking Clinical Study of Probiotic Efficacy on SIBO Using the SIMBA Capsule for Direct Sampling of the Small Intestine.

Montreal, September 10, 2024 – Lallemand Health Solutions announces the regulatory and ethics committee approval of their double-blind, randomized, placebo-controlled clinical study in patients with Small Intestinal Bacterial Overgrowth (SIBO). With this study, Lallemand Health Solutions positions itself as a pioneer in probiotic research using non-invasive and direct tools to study the microbiome composition and potential health applications of probiotics in the small intestine.

The study will evaluate the efficacy of the Bacillus subtilis R0179 strain at alleviating SIBO symptoms. In addition to using conventional methods of symptom tracking and stool microbiome analysis, the study will be a global first in assessing the probiotic’s impact in the small intestine using the SIMBA Capsule. This clinical trial is being conducted in collaboration with Nimble Science, the manufacturer of the new SIMBA Capsule, in Calgary, Canada. Dr. Christopher Andrews will act as the Principal Investigator and Drs. Eamonn Quigley (Houston Methodist, USA) and Jens Walters (Cork University, Ireland) as co-investigators.

The clinical trial titled, “The Safety and Efficacy of a Probiotic Intervention on SIBO and Related Gastrointestinal Symptoms” will enroll 105 subjects with SIBO to address the challenges posed by this condition. SIBO is postulated to involve excessive bacteria or dysbiosis in the small intestine, resulting in a variety of digestive symptoms such as bloating, abdominal pain, occasional constipation or diarrhea. In addition, the study will also evaluate whether the tested probiotic formulation can modulate the characteristic composition of the small intestinal microbiome and feces. The interaction between a probiotic and the small intestinal microbiome has not yet been tested, which also speaks to the innovative nature of the study. Furthermore, the existence of potential associations between SIBO and the metabolites found in the small intestine, fecal, or saliva samples will be explored.

You can access the details of the study here: NCT06317441.

Sylvie Binda, Vice-President Research and Development at Lallemand Health Solutions, said: “We are enthusiastic about collaborating with Nimble Science on this project and utilizing the innovative SIMBA capsule to collect small intestinal content samples. We anticipate that the data generated from this study will yield invaluable insights into the previously understudied small intestinal microbiome, which could provide new leads for therapeutic targets to help SIBO patients. The findings will contribute to our ongoing microbiome research program, enabling us to explore potential probiotic solutions for the management of this prevalent and debilitating condition.”

Dr. Christopher Andrews, a gastroenterologist, from Calgary Canada and Principal Investigator of the study, said: “SIBO presents a significant diagnostic and therapeutic challenge in gastroenterology, leading to delayed or incorrect diagnosis. The complex interplay between the gut microbiome, motility, and immune system has made it difficult to pinpoint the exact underlying cause in many cases. The SIMBA capsule offers great promise.”

Sabina Bruehlmann, Chief Executive Officer at Nimble Science Inc., said: “The use of our Small Intestine Microbiome Aspiration (SIMBA) system will significantly advance our understanding of SIBO and the impact of Lallemand’s novel probiotic on this critical, yet relatively unexplored region of the body. The small intestine plays a pivotal role in nutrition and various disease states. Its microbiome, distinct from that of the stool, offers a unique opportunity to accurately assess the effects of different nutritional interventions, including probiotics. Lallemand has recognized the potential of the SIMBA capsule from the outset. We are proud to collaborate with them on this groundbreaking research.”

About Lallemand Health Solutions
Lallemand Health Solutions is a privately-owned Canadian company specialized in the development, production and marketing of bacteria- and yeast-based probiotic supplements for human health, food applications, nutricosmetics and contract development and manufacturing (CDMO). Our mission is to apply leading-edge technologies and innovative scientific approaches to improve human health. We achieve this by understanding the interaction between people and their functional microbiome.

About Nimble Science
Nimble Science is a digital health company delivering first-in-class at home capsule based small intestinal fluid biopsy and multi-omic microbiome data capabilities via its SIMBA™ GI Health platform. Nimble’s SIMBA™ system is a single-use, ingestible passive capsule that allows for the non-invasive sampling of small intestinal contents. It is designed to open and absorb intestinal content after having passed the acid stomach environment and to mechanically seal before passing into the large bowel. It has distinct markers built in to allow radiographic tracking of its passage throughout the GI system. The SIMBA™ capsule has been developed by Nimble Science and has been clinically validated to collect an uncontaminated sample from the deepest and previously inaccessible regions of the small intestine – housing one of the most bioactive and critical microbial environments. Nimble’s technology, ease of administration and actionable health data insights are unparalleled in comparison with competing solutions, and Nimble has been actively partnering with industry leaders around the world to empower breakthrough health innovation spanning pharmaceuticals, diagnostics and consumer health R&D programs.

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