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This is an investigational fecal microbiota transplantation (FMT) therapy developed by the Psychiatric Hospital of the University of Basel (also known as University Psychiatric Clinics Basel or UPK) for the treatment of major depressive disorder (MDD). The therapy consists of oral frozen fecal microbiota transplantation capsules derived from healthy donors, administered as an adjuvant to standard antidepressant therapy in patients with moderate to severe MDD. The active ingredient is the fecal microbiota from healthy donors, which aims to restore gut microbial homeostasis and modulate the microbiome-gut-brain axis. The therapy was studied in a double-blind, placebo-controlled, randomized clinical trial (NCT03281044), which was terminated early for safety reasons after the FDA issued a general safety alert regarding FMT. [2, 4, 5] Case reports from the first two patients in the trial showed an improvement in depressive symptoms four weeks after transplantation. [2, 6, 8]
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