Study design
gastrointestinal symptoms
MINOR
In this randomised, double-blinded placebo-controlled crossover study, ileostomy patients consecutively received three different interventions (one serving per day, at breakfast 100 ml of intervention product) for 14 consecutive days each (± 1 day) with a 2-week wash-out in between. Moreover, the study started with a 2-week run-in period and ended with a 2-week run-out period. In both periods, study subjects did not follow a specific diet a part from to not be allowed to consumed products that could influence the study (described above). At the first and last day of each intervention period (referred to as “test days” and labelled V1–V2, V3–V4, and V5–V6 for the first, second and third intervention respectively), subjects were asked to visit the testing facility (Fig. Study design. All the subjects participated in 3 intervention periods, each encompassing 14 consecutive days (± 1 day) separated by a 2-week wash-out period and preceded by a run-in period of 14 days and followed by a 14-day run-out period. Three sampling schemes overlay the timeline of the study. Microbial composition scheme indicates the days at which subjects collected ileal effluent samples at home. SCFA and microbial activity indicates the days at which subjects will participate in test days, where they filled in VAS scales to assess gastrointestinal symptoms, received standardised meals and collected urine and ileal effluent samples. Sugar permeability test scheme indicates the days at which intestinal permeability was assessedAll intervention products were manufactured by Danone (Danone Nutricia Research, Palaiseau, France) with the intention to minimise their distinction on basis of appearance and taste, including the use of similar packaging and the use of the same flavour compounds, and fully blinded. Intervention products were 100 mL of milk fermented by Subjects participated in an approximately 100-day-long trial with 3 intervention periods (Fig. Compliance to dietary interventions and to the restrictions was checked by asking whether subjects consumed the products and whether they were able to abstain from food on the forbidden food list on every test day, revealing only a few minor deviations (Additional file 