Comment by derektank

It seems like FDA restrictions on clinical trials have really shot us all in the foot by depriving us the opportunity to collect data on this bacteria before it was made available as a supplement. There is clearly a demand for this product and it seems quite likely that Hillman et al could have gotten a cohort together to conduct a trial if they hadn't been faced with such extreme restrictions on testing. Why is informed consent not sufficient for participation in a RCT?