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

National Institute Of Allergy And Infectious Diseases

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Abstract

During the year 2024, the fecal transplant product originally used was no longer available, after successful completion of the trial for three subjects. Therefore, the study was paused and approvals (National Institutes of Health Institutional Review Board #000809 and U.S. Food and Drug Administration Investigational New Drug application #28209 and #30045) were successfully obtained to use an equivalent fecal transplant product for the remainder of the trial. During the fiscal year 2025, the new fecal transplant product has been successfully procured, and enrollment has now restarted and will continue.