Bacteria living in the large intestine (collectively known as the ‘gut microbiome’) are essential for healthy functioning of the gut. A person with a healthy microbiome has many different types of bacteria that all work together to help the gut function properly. Research has found that in some diseases of the bowel, the microbiome is missing certain beneficial bacteria or has too much unhealthy bacteria, causing an imbalance in the gut.
One common example of how unhealthy bacteria can dominate the microbiome is a bacterium called Clostridium difficile (also known as C. difficile or C. diff). C. difficile is commonly found in most people’s digestive tract and doesn’t cause a problem unless there is a shortage of beneficial bacteria in the gut (called dysbiosis). When there are not enough healthy bacteria to keep C. difficile in check, C. diff can rapidly grow out of control. An overgrowth of C. difficile can create an infection that releases toxins that inflame the intestines and produces symptoms, which can range from mild to those that are potentially life threatening.
To address microbiome-related problems such as C. difficile, Seres Therapeutics developed Ecobiotic® therapies, investigational research medications that are designed to establish balance in the disrupted intestinal environment. They are called “investigational research medications” because they are currently being studied in clinical trials and are not yet available on the market. The aim of Ecobiotic® therapies is to correct bacterial imbalance, improve the immune system, and restore the gut’s normal functioning.
Seres Therapeutics is developing Ecobiotic® therapies including an investigational research medication called SER-109 to address C. difficile infection in patients who had recurrent C. difficile infection. Research using SER-109 has shown significant improvement in microbiome diversity. The Federal Drug Administration (FDA) designated SER-109 as a Breakthrough Therapy in 2015, which means this research medication has the opportunity for priority review from the FDA.
Breaking unhealthy microbial networks by establishing healthy microbiome communities.
The research medication is composed of bacterial spores (the inactive form of bacteria) purified from a healthy donor and placed in capsules that are taken orally. These spores are common in the healthy gut but are often depleted in the intestines of C. difficile and ulcerative colitis patients.
This study is to determine if SER-109 will help replenish beneficial bacteria in the intestines and prevent recurrent C. difficile infection.
Researchers hope that introducing normal microbes into the gut via Ecobiotic® therapies will encourage the growth of a healthy bacterial community and restore diversity to the microbiome for patients with diseases of the digestive tract including ulcerative colitis and C. difficile infection.Can I Take Part?
Frank DN, Amand AL, Feldman RA, et al. Molecular-phylogenetic characterization of microbial community imbalances in human inflammatory bowel diseases. Proceedings of the National Academy of Sciences. 2007; 104(34): 13780-13785
Khanna S, Pardi DS, Kelly CR, et al. A novel microbiome therapeutic increases gut microbial diversity and prevents recurrent Clostridium difficile infection. Journal of Infectious Diseases. 2016; 214(2):173-181