73
Participants
Start Date
December 31, 2013
Primary Completion Date
July 31, 2015
Study Completion Date
September 30, 2015
Mixture of three Bifidobacteria
This investigation will be a randomized, double-blind, placebo-controlled, cross-over trial. The study will include 70 children with FD or IBS and will be articulated in 16 weeks as follows. Fifty-nine children (median age 11.2 years, range 5.2-17.9) with IBS and FD were randomized to receive either a mixture of three Bifidobacteria or a placebo for 6 weeks. At the end, after a 2-week-''washout'' period, each patient was switched to the other group and followed for 6 further weeks. At baseline and at follow-up, patients and/or their parents completed a dairy for bowel habit and gastrointestinal symptoms, and a quality of life (QoL) questionnaire.
"University of Naples Federico II Italy", Naples
Federico II University
OTHER