Safety of the trial
diarrheal, bloating, rumbling, pain
We evaluated same number of healthy and diarrheal children (30 each) 1–3 years old for the digestive tolerability and acceptability of Fibersol-2 before initiation of the randomized trial, where we found the product was safe and well tolerated based on disappearance or improvements in abdominal symptoms, like distension, pain, rumbling and bloating in both groups of children (journal.pone.0274302), henceforth these were the variables selected to monitor the safety of the trial.