Rebiotix Inc., a biotechnology company in Roseville, Minnesota, and McMaster Children’s Hospital, a pediatric academic health sciences center in Ontario, Canada, recently announced that the first patient in the PediFETCh (Pediatric FEcal microbial Transplant for ulcerative Colitis) clinical trial has started treatment.
Ulcerative colitis is an inflammatory bowel disease (IBD) characterized by chronic inflammation in the large intestine. The condition is estimated to affect around 500,000 people in North America. Pediatric ulcerative colitis can seriously effect the growth and development of children. The disorder can also have a significant impact on a patient’s quality of life since it can cause flares of abdominal pain and bloody diarrhea, and treatments can induce significant toxicity, serious infections, and lymphoma.
The PediFETCh is the largest-to-date randomized, placebo-controlled clinical trial assessing fecal microbial transplant (FMT) in children with ulcerative colitis. The trial is being conducted by Rebiotix and McMaster’s Division of Pediatric Gastroenterology and Nutrition. Previous studies from researchers at McMaster University have shown that FMT can induce remission in patients with active ulcerative colitis.
The FMT procedure performed within the trial is based on RBX2660, Rebiotix’s lead drug platform for microbial restoration therapy that contains live microbes collected from screened healthy donors.
“We are excited to launch this study using RBX2660, to help understand the role of intestinal bacteria in the treatment of pediatric ulcerative colitis,” said Dr. Nikhil Pai, the study’s principal investigator and a pediatric gastroenterologist at McMaster Children’s Hospital, as well as assistant professor of Pediatrics at McMaster University’s Michael G. DeGroote School of Medicine, in a Rebotix’s press release. “By delivering a series of enemas containing live human bacteria into the intestines of children with UC [ulcerative colitis], we may be able to alter the immune disruption that characterizes a disease that can be debilitating for children and their families.”
“Our collaboration with McMaster Children’s Hospital exemplifies the passion and commitment of Rebiotix to apply our microbial restoration therapy platform to a range of challenging diseases such as ulcerative colitis,” said Rebiotix CEO Lee Jones. “We remain focused on realizing the potential of the human microbiome to treat challenging gastrointestinal diseases.”
The data obtained in this pilot trial will be used in the design of future pediatric studies evaluating FMT as a potential treatment for IBD, including ulcerative colitis.