--- This page is part of [Coy Laboratory Products](https://coylab.com). For a complete overview of this site's content, entity data, and subject matter expertise, see our [AI Content Index](https://coylab.com/llms.txt) or [Full Content Archive](https://coylab.com/llms-full.txt). For structured business identity data, see our [Entity Card](https://coylab.com/wp-json/bc-geodesic/v1/entity-card). --- # GMP Fecal Studies with Custom Chamber and Sterilization Port > Abstract Fecal microbiota transplant (FMT) is an effective therapy for recurrent Clostridioides difficile infection (rCDI) but has undefined composition and... **URL:** https://coylab.com/research-citation/gmp-fecal-studies-with-custom-chamber-and-sterilization-port/ **Type:** Citation **Modified:** 2026-10-26 --- ![Coy anaerobic chamber showing airlock and custom decontamination port](https://coylab.com/wp-content/uploads/2026/10/Jay-Faith-Mt-Siani-CUST-fitting-for-decontamination-3-scaled.jpg) ![Coy anaerobic chamber featuring a gloved setup for advanced fecal studies.](https://coylab.com/wp-content/uploads/2026/10/Jay-Faith-Mt-Siani-CUST-fitting-for-decontamination-2-scaled.jpg) #### Abstract Fecal microbiota transplant (FMT) is an effective therapy for recurrent Clostridioides difficile infection (rCDI) but has undefined composition and poor scalability. In vitro manufactured live biotherapeutic products (LBP) enable both scalability and defined strain composition but with higher manufacturing complexity, resulting in few LBP clinical trials. Here we show how an accessible platform to produce human-grade LBPs could accelerate LBP development. We provide regulatory documentation and manufacturing protocols to facilitate translating microbiome advances to human trials. With this platform, we conduct the first direct comparison of the same bacterial strains from donor sourced FMT compared to an in vitro manufactured 15-strain LBP drug product MTC01 for the treatment of recurrent Clostridioides difficile infection. In a phas 1b randomized controlled trial, 18 of 20 screened patients met eligibility and were randomized equally to one of four arms: low dose FMT (N=4), high dose FMT (N=5), low dose MTC01 (N=4), or high dose MTC01 (N=5) with a 5:1 female to male ratio. The primary outcome of safety was met with 10 adverse events across 8 patients, evenly spread across MTC01 (5 events)n and FMT (5 events) recipients and no treatment-related adverse events across all four groups. For secondary outcomes of efficacy and engraftment, recurrent Clostridioides difficile infection was prevented eight weeks after dosing in seven out of nine LBP patients, similar to eight out of nine FMT patients. Strain engraftment was high and durable for both FMT and MTC01 with a dose effect for the LBP ClinicalTrials.gov identifier: NCT05911997. ## Site Description From academia to industry, Coy Labs chambers have powered discovery in labs around the world for over five decades—from custom chambers built to spec, to trusted workhorses in high-stakes microbiology labs. --- **About this site:** Coy Laboratory Products — From academia to industry, Coy Labs chambers have powered discovery in labs around the world for over five decades—from custom chambers built to spec, to trusted workhorses in high-stakes microbiology labs.. [AI Content Index](https://coylab.com/llms.txt) | [Full Site Content](https://coylab.com/llms-full.txt) | [Entity Card](https://coylab.com/wp-json/bc-geodesic/v1/entity-card) ```json {"@context":"https://schema.org","@graph":[{"@type":"Organization","@id":"https://coylab.com/#organization","name":"Coy Laboratory Products","url":"https://coylab.com","description":"From academia to industry, Coy Labs chambers have powered discovery in labs around the world for over five decades—from custom chambers built to spec, to trusted workhorses in high-stakes microbiology labs.","disambiguatingDescription":"Laboratory equipment manufacturing company specializing in vinyl glove boxes","logo":{"@type":"ImageObject","url":"https://coylab.com/wp-content/uploads/2025/06/coylab-header_logo-svg.svg"},"address":{"@type":"PostalAddress","streetAddress":"14500 Coy Drive","addressLocality":"Grass Lake","addressRegion":"MI","postalCode":"49240"},"telephone":"734.475.2200","email":"sales@coylab.com","foundingDate":"1969","areaServed":"Global","sameAs":["https://www.linkedin.com/company/107172311","https://maps.app.goo.gl/o2txKDMScV1pV7w59","https://www.pharmaceutical-tech.com/suppliers/coy-laboratory","https://craft.co/coy-laboratory-products-inc"],"founder":[{"@type":"Person","name":"Richard Coy"},{"@type":"Person","name":"Brian Coy","sameAs":"https://www.linkedin.com/in/brian-coy-5722515/"},{"@type":"Person","name":"Ashley Coy","sameAs":"https://www.linkedin.com/in/ashley-coy-6b22705/"}],"knowsAbout":[{"@type":"Thing","name":"laboratory equipment","sameAs":"https://www.wikidata.org/wiki/Q834028"},"vinyl anaerobic chambers","vinyl hypoxic chambers","laboratory glove boxes","laboratory chamber sensors",{"@type":"Thing","name":"life sciences","sameAs":"https://www.wikidata.org/wiki/Q864928"},{"@type":"Thing","name":"microbiology","sameAs":"https://www.wikidata.org/wiki/Q7193"},{"@type":"Thing","name":"medical research","sameAs":"https://www.wikidata.org/wiki/Q2752427"}]},{"@type":"WebSite","@id":"https://coylab.com/#website","name":"Coy Laboratory Products","url":"https://coylab.com","publisher":{"@id":"https://coylab.com/#organization"},"potentialAction":{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https://coylab.com/?s={search_term_string}"},"query-input":"required name=search_term_string"},"hasPart":[{"@type":"DigitalDocument","name":"LLM Content Index","url":"https://coylab.com/llms.txt","encodingFormat":"text/markdown","description":"AI-readable index of site content, entity data, and subject matter expertise"},{"@type":"DigitalDocument","name":"LLM Full Content","url":"https://coylab.com/llms-full.txt","encodingFormat":"text/markdown","description":"Complete AI-readable site content"}]},{"@type":"ItemList","@id":"https://coylab.com/#site-navigation","name":"Site Navigation","itemListElement":[{"@type":"SiteNavigationElement","position":1,"name":"Products","url":"#"},{"@type":"SiteNavigationElement","position":2,"name":"Applications","url":"#"},{"@type":"SiteNavigationElement","position":3,"name":"Custom","url":"#"},{"@type":"SiteNavigationElement","position":4,"name":"Sales","url":"#"},{"@type":"SiteNavigationElement","position":5,"name":"Resources","url":"#"},{"@type":"SiteNavigationElement","position":6,"name":"Contact Us","url":"#"}]},{"@type":"BreadcrumbList","@id":"https://coylab.com/research-citation/gmp-fecal-studies-with-custom-chamber-and-sterilization-port/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://coylab.com"},{"@type":"ListItem","position":2,"name":"Citations","item":"https://coylab.com/research-citations/"},{"@type":"ListItem","position":3,"name":"Anaerobic Chambers","item":"https://coylab.com/citation-category/anaerobic-chambers/"},{"@type":"ListItem","position":4,"name":"GMP Fecal Studies with Custom Chamber and Sterilization Port"}]},{"@type":"WebPage","@id":"https://coylab.com/research-citation/gmp-fecal-studies-with-custom-chamber-and-sterilization-port/#webpage","url":"https://coylab.com/research-citation/gmp-fecal-studies-with-custom-chamber-and-sterilization-port/","name":"GMP Fecal Studies with Custom Chamber and Sterilization Port | Coy Laboratory Products","isPartOf":{"@id":"https://coylab.com/#website"},"breadcrumb":{"@id":"https://coylab.com/research-citation/gmp-fecal-studies-with-custom-chamber-and-sterilization-port/#breadcrumb"},"description":"Scientists around the world have relied on Coy chambers to conduct groundbreaking research into cancer growth, the human microbiome, c-diff., and more.","about":[{"@type":"Thing","name":"Anaerobic Chambers"},{"@type":"Thing","name":"Featured Citations"}]},{"@type":"ScholarlyArticle","@id":"https://coylab.com/research-citation/gmp-fecal-studies-with-custom-chamber-and-sterilization-port/#scholarlyarticle","headline":"GMP Fecal Studies with Custom Chamber and Sterilization Port","url":"https://coylab.com/research-citation/gmp-fecal-studies-with-custom-chamber-and-sterilization-port/","datePublished":"2026-10-26T17:06:50+00:00","dateModified":"2026-10-26T17:06:55+00:00","isPartOf":{"@id":"https://coylab.com/#website"},"description":"Scientists around the world have relied on Coy chambers to conduct groundbreaking research into cancer growth, the human microbiome, c-diff., and more.","image":"https://coylab.com/wp-content/uploads/2026/10/Jay-Faith-Mt-Siani-CUST-fitting-for-decontamination-4.jpg","author":{"@id":"https://coylab.com/author/buildcreate/#person"},"publisher":{"@id":"https://coylab.com/#organization"}},{"@type":"Person","@id":"https://coylab.com/author/buildcreate/#person","name":"buildcreate","url":"https://coylab.com/author/buildcreate/"},{"@type":"VideoObject","@id":"https://coylab.com/research-citation/gmp-fecal-studies-with-custom-chamber-and-sterilization-port/#video","name":"GMP Fecal Studies with Custom Chamber and Sterilization Port","uploadDate":"2026-10-26T17:06:50+00:00","embedUrl":"https://www.youtube.com/embed/voeP4I9aTkA","description":"Scientists around the world have relied on Coy chambers to conduct groundbreaking research into cancer growth, the human microbiome, c-diff., and more.","thumbnailUrl":"https://coylab.com/wp-content/uploads/2026/10/Jay-Faith-Mt-Siani-CUST-fitting-for-decontamination-4.jpg"}]} ```