Principal Investigator: Caterina Oneto MD
This phase 1 trial features an innovative approach to the treatment of Ulcerative Colitis – modification of the microbiome in order to induce colitis remission. Patients with mild to moderate ulcerative colitis are eligible. Patients on biologic therapies within 3 months of screening will be excluded. Patients who meet inclusion criteria and have no exclusion criteria will undergo a colonoscopy. If there is mild to moderate colitis of sufficient extent (at least 15 cm. of disease from the anal verge), the patient will be randomized to pretreatment with vancomycin or placebo followed by daily or weekly dosing of study drug (SER-287, a preparation of purified Eubacterial spores) for 8 weeks. There is a placebo arm (10/55 patients). Patients are followed clinically and by laboratory assessments, including stool microbiome assays. Follow-up colonoscopy to assess colitis response will be performed at 8 weeks. Safety assessments including telephone calls and office visits will be carried out for 38 weeks in total.
Please contact our Clinical Trial team if you have a patient who may be eligible.
Contact No: (212) 889-5544 x 152