NCT01498666

Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: BioGaia AB · Industry
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Abdominal Pain

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L. reuteri protectis	1 tablet once daily for 4 weeks
DIETARY_SUPPLEMENT	Placebo tablet	1 tablet once daily for 4 weeks

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-12-23
• Last updated: 2021-06-02

Locations

2 sites across 1 country: Italy