Most people believe that, if you want to conduct clinical research, the best path is going into academic medicine. However, for physicians who want both the benefits of practicing in the community setting and a career in research,
Our practices, Capital Digestive Care in Silver Spring, Md., and the PACT-Gastroenterology Center in Hamden, Conn, have been conducting clinical trials for many years on serious diseases such as inflammatory bowel disease, gastroparesis, and most recently, recurrent infection of Clostridioides difficile. We both also worked on the National Institutes of Health–sponsored Anal Cancer/HSIL Outcomes Research (ANCHOR) study.
Academic setting vs. private practice
Dr. Paul Feuerstadt
Research in our practices is similar to the academic setting with regards to how studies are conducted and structured since everyone involved in the study follows the same protocol. The benefit of being in a community setting is that you have a wide range of patients that you are seeing every day.
Getting involved in research is not for everyone, but for those who do get involved, the decision is a rewarding one that can make a significant difference in patients’ lives. Offering new therapeutics for disease states is a powerful tool for a provider, and it is exciting and rewarding to engage in the research considering new mechanisms of action and new approaches to treating diseases.
Finding a better treatment for C. difficile
For example, C. difficile is common in older people who’ve received antibiotics for other infections, especially residents of long-term care facilities. These residents have frequent antibiotic exposure and are already vulnerable to infection because of advanced age, multiple comorbid conditions, and communal living conditions. Once a case of C. difficile is diagnosed in a nursing home, it can spread through contaminated equipment, environments, or hands.
The treatment for C. difficile is to control the bacteria with antibiotics, but spores remain, so after a few days in certain people the spores germinate, and the C. difficile returns: a recurrence. It used to be that, after a second reoccurrence, you would send the patient for a fecal transplant, which was a scarce resource and a challenging process.
To perform a fecal transplant, you would need a spouse or a family member to provide a stool sample. After their stool was tested, the family member would need to process their stool in a blender with saline and draw it up in syringes. Once you had the material, the patient would need to go through a full colonoscopy to infuse the material into the colon. Of course, increased restrictions and safety precautions from the COVID-19 pandemic have made fecal transplants even more complex.
Given all these challenges, conducting research considering microbiota-based live biotherapeutics, the term the Food and Drug Administration uses for pharmaceutically produced forms of fecal microbiota transplantation, is very appealing. There are several different formulations that have come through clinical trials recently including RBX-2660, SER-109, and CP101.
Dr. Louis Korman
SER-109 is an orally taken treatment produced by Seres Therapeutics. Once patients with acute recurrence of C. difficile are treated with standard antibiotics, they are given a course of four SER-109 capsules for 3 days. The results of the SER-109 study were published recently in the New England Journal of Medicine. This is the first phase 3 clinical trial published on a microbiota-based live biotherapeutic treatment, and the results were exciting, showing a clear efficacy benefit for SER-109.
In the case of C. difficile, we understand the deficiency that SER-109 replaces. SER-109 changes the microbiome within the colon so that the environment becomes less hospitable to C. difficile, which helps to better resist recurrence. With this therapy, we are replenishing the good bacteria, which helps to keep C. difficile from regerminating.
The therapy showed excellent results through the significant difference in rates of recurrence seen in patients with recurrent C. difficile infection following 8 weeks of follow-up. This is exciting because we believe the future of therapeutics for many diseases might involve this type of manipulation of the microbiota, and this is the first to show such an impact with this class of therapeutic.
