Clinical Trial: Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old
Brief Summary: The present clinical trial will examine the use of L. reuteri Protectis in children with functional abdominal pain. The aim of the study is to evaluate the use of L. reuteri Protectis on pain (severity and frequency) in children of 8-14 years old and with diagnosis of functional abdominal pain (FAP).
Detailed Summary: Subject will be asked to consume a tablet every day for 4 weeks. Supplementation will be stopped after 4 weeks, and the subjects will be followed up for an additional 4 weeks. The subjects will complete a diary to record frequency and intensity of pain, use of medication, deviation from the usual diet, physical activities, and absence from school and other activities. Gastrointestinal symptoms are assessed.
Sponsor: BioGaia AB
Current Primary Outcome: Primary endpoint [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Secondary endpoint [ Time Frame: 56 days ]
Original Secondary Outcome: Same as current
Information By: BioGaia AB
Dates:
Date Received: December 19, 2011
Date Started: December 2011
Date Completion:
Last Updated: December 2, 2013
Last Verified: December 2013