300
Participants
Start Date
October 31, 2012
Primary Completion Date
June 30, 2013
Study Completion Date
October 31, 2013
Administration of L.reuteri in children with abdominal pain
Group of around 75 children which will receive L. reuteri at a dose 100.000.000 CFU per dose for 3 months. The active study product consists of a citrus flavored 450 mg chewable tablet containing freeze-dried L. reuteri DSM 17938. The study product is a convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of freeze-dried L. reuteri, isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid. The total viable count of L. reuteri is 1x100.000.000 live bacteria (CFU)/tablet.
Administration of placebo in children with abdominal pain
Group of around 75 children which will receive placebo for 3 months. The placebo consists of a citrus flavored 450 mg chewable convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid.
Administration of L.reuteri in children with constipation
Group of around 75 children which will receive L. reuteri at a dose 100.000.000 CFU per dose plus lactulose in a dose 1-3 ml/kg, according to the stool frequency and consistency, for 3 months. The active study product consists of a citrus flavored 450 mg chewable tablet containing freeze-dried L. reuteri DSM 17938. The study product is a convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of freeze-dried L. reuteri, isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid. The total viable count of L. reuteri is 1x100.000.000 live bacteria (CFU)/tablet.
Administration of placebo in children with constipation
Group of around 75 children which will receive placebo plus lactulose in a dose 1-3 ml/kg, according to the stool frequency and consistency, for 3 months. The placebo study product consists of a citrus flavored 450 mg chewable convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid.
RECRUITING
"University Hospital Centre Sisters of Mercy", Zagreb
Collaborators (1)
BioGaia AB
INDUSTRY
Sisters of Mercy University Hospital
OTHER