The Duchossois Family Institute (DFI) at the University of Chicago is poised to initiate clinical trials in January, focusing on the restoration of gut microbiomes in patients with compromised gut health. These trials mark a significant step in addressing the challenges of bacterial loss in hospitalized patients, particularly those undergoing cancer therapy or transplant surgery.
GMP Facility and Bacterial Strain Production
Having completed construction of its new facility in 2023, the DFI now possesses the capability to manufacture live biotherapeutic products. The in-house Good Manufacturing Practices (GMP) facilities have successfully produced eight bacterial strains, with three already encapsulated for clinical trials. This capability positions the DFI ahead of other academic institutions, as similar facilities are typically found in large pharmaceutical companies.
Clinical Trial Design and Objectives
The clinical trials will involve administering each of the eight bacterial strains to patients in separate pills to measure their individual and combined impact on the gut microbiome. Researchers will analyze fecal matter samples to determine clinical trial outcomes, assessing the retention and function of these strains within the gut. The DFI aims to identify bacterial consortia that can effectively rebuild the gut microbiome and mitigate the long-term negative effects of its destruction.
Christopher Lehmann, DFI’s in-house infectious disease specialist, likened the strains to a "varsity team," emphasizing the ability to swap out components to optimize functionality. Eric Pamer, DFI Director, noted that the selected strains are common to health-promoting microbiomes worldwide and produce essential metabolites like butyrate and secondary bile acids.
Patient Enrollment and Study Parameters
The first phase of the clinical trial will involve eight individuals selected from consenting patients within the UChicago Medicine hospital system. This controlled approach allows researchers to adhere to initial safety guidelines set by the FDA and closely monitor the study population. Matthew Odenwald, the in-house hepatologist, emphasized that the ultimate goal is to improve patient outcomes by using microbiome reconstitution strategies based on findings from observational studies.
Significance of Microbiome Research
Hospitalized patients can experience a significant loss of gut bacteria, sometimes losing 90% to 95% of their gut microbiome. Researchers at the DFI aim to address the critical question of how adults can rebuild their gut microbiome after such losses, as some individuals never recover the lost bacterial strains. The DFI's research seeks to identify and utilize bacterial strains that consistently support the rebuilding of the gut microbiome and reduce the long-term negative effects of its destruction.
