A pilot study of fecal microbiota transplantation for Chronic Granulomatous Disorder Associated Colitis (CGD-AC)

National Institute Of Allergy And Infectious Diseases

Investigators

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Abstract

During FY22 the protocol for the clinical trial was designed and underwent Scientific Review. An Investigational New Drug (IND#28209) application with the U.S. Food and Drug Administration was successfully completed. Institutional Review Board approval was obtained. Fecal Microbiota Transplant material was obtained from Openbiome and all contracts executed. Trial databases and laboratory standard operating procedures were created. A safety monitoring committee was convened and the first meeting conducted. The site initiation visit for the trial was completed and the site activated. The first subject on the trial was enrolled.