Hospitalized patients can lose anywhere from 90 percent to 95 percent of all the bacteria existing in their gut, particularly those patients suffering from severe medical conditions requiring a range of antibiotics, such as cancer therapy or transplant surgery. Researchers are unsure how adults in particular would rebuild their gut microbiome after having it reduced. In some adults, the lost bacterial strains never return.
The Duchossois Family Institute (DFI), a microbiome research facility at UChicago, completed construction of a new facility in 2023 that allows it to manufacture live biotherapeutic products. Now, it is preparing to start clinical trials in January using strains of bacteria manufactured at the new facility. These trials will allow it to address questions surrounding loss of gut bacteria.
DFI opened on March 24, 2017, and was founded with a $100 million gift from Janet and Craig Duchossois and The Duchossois Family Foundation. According to its website, the institution “aims to maximize good health and the economic, social, and personal benefits it delivers.” Its researchers test bacterial strains that they hope can consistently support the rebuilding of the gut microbiome and reduce the long-term negative effects of its destruction. Through clinical trials, researchers at the DFI hope to measure the impact of pills containing bacterial strains on gut microbiomes and their retention in the gut.
Working with the FDA, DFI staff secured approval in April 2024 to begin the first phase of the clinical trials. Since then, the in-house Good Manufacturing Practices (GMP) facilities have produced eight strains of bacteria. As of now, three out of those eight strains have been prepared and encapsulated for clinical trials. The bulk of the manufacturing is projected to take place in December.
Each of the eight strains will be given to patients in separate pills to measure their individual and group impact. In an interview with the Maroon, DFI’s in-house infectious disease specialist Christopher Lehmann likened the strains to a “varsity team.”
“If it turns out that one component of that varsity team—let’s say the carbohydrate degradation or the bile acid processing arm of the varsity team—doesn’t work, we can swap it out with another set of members that should perform that function,” Lehmann said. “And that’s how we get the other consortia for the other stages of the clinical study.”
At the moment, researchers have found 17 bacterial strains that promote gut health globally despite widely varying microbiomes.
“We recognize [these strains] as being common to microbiomes that are health-promoting around the world,” DFI Director Eric Pamer said. “These are basic metabolites, like butyrate and secondary bile acids and other metabolites that are produced, that we suspect may be foundational to having a healthy microbiome.” Pamer said these strains could be critical to the recovery of patients after medical interventions.
“[The trial is] step one of any FDA study, but also a chance to ask some more interesting scientific questions,” Matthew Odenwald, the in-house hepatologist, told the Maroon. “Ultimately, our goal is to take the findings from these and the findings from our observational study where we found that microbiome derangements are associated with poor outcomes and hopefully do studies with these microbiome reconstitutions and hopefully improve patient outcomes.”
Enrollment of participants in the trial will begin shortly. The first phase of the clinical trial will consist of eight individuals. Initial clinical trials won’t be public, with individuals being selected from consenting patients within the UChicago Medicine hospital system. These restrictions will help control the study population and fit within the initial safety guidelines set by the FDA. Clinical trial outcomes will be determined using a fecal matter sample, a technique pioneered at the University of Chicago, according to Pamer. A number of specialists in different scientific and medical practice fields will be analyzing the results of the clinical trials.
The DFI’s nonprofit status due to funding from the Duchossois family and its unique ability to manufacture drugs in-house at the GMP facility has allowed researchers more time to focus on their research.
“These types of facilities are only seen typically in Big Pharma, you know, Pfizer, Baxter,” DFI Director of Manufacturing Joseph Sprydina said in an interview with the Maroon. “So for the University to be able to produce the highest quality biotherapeutics puts us ahead of other academic institutions.”
