Our Approach to Transplantation Methods
The NanoGAS®-FMT we provide is a specialized approach focused on process management and implementation procedures within the field of Fecal Microbiota Transplantation (FMT).
Various administration methods exist for FMT, such as the use of endoscopes, oral capsules, or pharmacological pre-treatments.
In the NanoGAS®-FMT protocol, we utilize an administration method via a thin rubber tube. In collaboration with The Association for Clinical Research of Fecal Microbiota Transplantation Japan, we employ this method specifically to facilitate treatment in an outpatient setting.
The content on this page outlines “differences in implementation methods and process control” and does not imply a reduction in burden or the superiority of clinical outcomes.
Utilization of NanoGAS® Water
NanoGAS®-FMT incorporates NanoGAS® water into the manufacturing process of the bacterial solution.
NanoGAS® water is characterized by its ability to stably maintain nano-sized bubbles over extended periods.
Due to their specific surface charge characteristics and microscopic size, nano-sized bubbles are known to remain stable within liquid.
By leveraging these physical characteristics, we utilize it as a tool for process control and concentration homogenization during bacterial solution production.
Preparing the optimal environment for handling bacteria during the manufacturing process is crucial in Fecal Microbiota Transplantation, and NanoGAS® water is integrated as part of that system.
This section explains the technical characteristics pertaining to the process management of bacterial solution manufacturing.
Development Background
NanoGAS®-FMT is an initiative whose implementation methods and bacterial solution manufacturing procedures were developed through the research and development efforts of Shinbiosis Corporation.
In developing Fecal Microbiota Transplantation, we meticulously design procedures considering multiple factors, such as bacterial solution storage methods, management of oxygen exposure, administration frequency, and concentration settings.
The stool used for transplantation is supplied by “Japanbiome®,” the affiliated donor bank of Shinbiosis Corporation.
Donors are registered after undergoing a rigorous screening process consisting of extensive criteria, including general blood tests and stool tests, followed by regular re-inspections.
These inspection items are established with reference to guidelines and standards published domestically and internationally.
FMT methodologies include the use of both fresh stool on the same day and tested, frozen samples.
In NanoGAS®-FMT, we use pre-tested frozen stool and have established strict standards for bacterial solution manufacturing and storage procedures.
The concentration of the bacterial solution is adjusted within the range of 1:10 to 1:45, referring to benchmarks established in domestic and international research.
The multi-session administration protocol is also based on research reports and case studies from overseas stool banks.
Collaboration with Research Groups and Academic Activities
NanoGAS®-FMT undergoes continuous review and optimization within an academic network of medical professionals and researchers.
We collaborate with The Association for Clinical Research of Fecal Microbiota Transplantation Japan to share information through training sessions, academic conferences, and case study meetings.
The association is developing frameworks to ensure ethics and safety regarding FMT, data collection, and reporting of Adverse Events. The initiatives of NanoGAS®-FMT are conducted in accordance with that framework.
In Japan, clinical studies related to FMT are being conducted by national research institutions and university hospitals. Research targeting various diseases, including ulcerative colitis, recurrent Clostridioides difficile infection(rCDI), and oncology, has been published.
Details of the research can be confirmed on the Ministry of Health, Labour and Welfare’s “Clinical Research Information Portal Site.”
▶ https://rctportal.mhlw.go.jp/en
Summary
NanoGAS®-FMT is an approach that emphasizes implementation methods, process control, and inspection systems in the field of Fecal Microbiota Transplantation.
While referring to technical and academic standards, we strive to deepen the understanding of the intestinal microbiome and accumulate clinical data.
The content of this page is intended to provide technical and systemic information and does not guarantee treatment efficacy or safety.
