Protocol Amendment 1 became effective on 03 MAR 2015, prior to inclusion of the first subject into the study, and introduced several clarifications regarding study schedule and stool collection, physical examination, body weight measurement, and diary data. Protein range intake was adapted from 50-60 g to 50-90 g since this was considered more appropriate for adult subjects. Several concomitant medication criteria were changed: Steroids, as well as prebiotic or probiotic drugs, were allowed; however, such drugs should have been taken by the subject for more than 4 weeks before start of the study at the prescribed dose, and the dose should not have been changed during the course of the study. Fat- or protein-containing nutritional supplements were prohibited because the determination of the coefficient of fat absorption and the coefficient of nitrogen absorption must be based on diet and not on content of nutritional supplements. Additionally, the amendment prohibited subjects from being treated with intravenous antibiotics during the study because of possible effects on gastrointestinal motility. Since Protocol Amendment 1 became effective prior to first subject first visit, no impact on the study was expected to occur.

Protocol Amendment 2 became effective on 24 APR 2015 and allowed a prolonged screening period of an extra 14 days inclusive, introduced the possibility of re-screening, and clarified that the daily fat intake could be 100 to 105 g to account for an acceptable variation in meals of 5 g of dietary fat. No impact on the study results was expected to occur by adoption of Protocol Amendment 2.