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Melatonin regulates intestinal immune function and down-regulates inflammatory response In prolonged paradoxical sleep deprivation mouse model, with the activation of the HPA, a large amount of cortisol were released into the systemic circulation, which would mediate the disturbance of intestinal microbiota (Gao et al., 2021)

That trial would help determine the optimal dose to advance into larger late-stage studies required for regulatory approval