OpenBiome-sponsored IBD studies begin enrolling patients

Nonprofit stool bank support four clinical trials investigating the efficacy of FMT in treating Inflammatory Bowel Disease (IBD)

Medford, MA – Researchers at OpenBiome are supporting four clinical trials investigating the safety and efficacy of fecal microbiota transplantation (FMT) in treating patients with inflammatory bowel diseases (IBD), including Crohn’s disease and ulcerative colitis. Led by researchers from Cornell University, Beth Israel Deaconess Medical Center, the University of Vermont, and the University of California in San Francisco, these studies have all begun recruiting patients and will be important steps for our collective understanding of how FMT can be used to treat new indications beyond C. difficile.

FMT is a procedure in which a stool preparation from a healthy human donor is infused into the colon of a patient, most often via colonoscopy, enema, or a plastic tube inserted through the nose leading to the intestines. FMT has long been established as an effective therapy for the treatment of recurrent Clostridium difficile infection, with a cure rate of 85-90% across multiple randomized controlled trials. Growing evidence suggests FMT may also be a powerful treatment for IBD patients, who currently have few effective treatment options.

Included among the four IBD studies are two randomized controlled trials led by Dr. Peter Moses of the University of Vermont and Dr. Alan Moss of Beth Israel Deaconess Medical Center. Moses is conducting a double-blind randomized study evaluating the safety and efficacy of FMT in a sample of 20 patients with ulcerative colitis. Moss is leading a multi-center randomized trial (n=44) in collaboration with Brigham & Women’s Hospital, Boston Medical Center, and the Massachusetts Institute of Technology to determine if FMT can safely alleviate the debilitating symptoms of Crohn’s disease in patients who have had intestinal resection.

Additionally, OpenBiome is supporting two prospective pilot studies led by Dr. Carl Crawford of Cornell University and Dr. Najwa El-Nachef of the University of California-San Francisco. These single group studies aim to explore whether FMT can safely control the symptoms associated with inflammatory bowel disease. While Elnachef’s study is enrolling patients (n=60) with various forms of IBD, Crawford is focusing on FMT’s long-term safety in managing ulcerative colitis patients (n=20) specifically.

Patients who are looking for more information on how to enroll can view these studies by clicking on the researchers’ names above and find more details on clinicaltrials.gov.

Since its launch in 2012, OpenBiome has been dedicated to expanding safe access to FMT for patients suffering from recurrent C. difficile infections and catalyzing research into the microbiome and its role in human health. Given the increasing connection between the microbiome and IBD, OpenBiome is excited to push forward its mission by collaborating with leaders in the field of fecal microbiota transplantation to discover new applications of FMT that may help improve quality of life for patients living with Crohn’s or ulcerative colitis.

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