NCT01719107

Efficacy of Dietary Supplementation With Lactobacilllus Reuteri DSM 17938 on Functional Abdominal Pain (FAP) in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Aghia Sophia Children's Hospital of Athens · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to investigate the effect of L. reuteri DSM 17938 on pain frequency and severity in children of 5-16 years old and with diagnosis of FAP.

Detailed description

This is a randomized, double-blind, placebo-controlled study. Subjects between of 5-16 years of age with FAP as defined in the Rome III criteria and with pain severity of at least 40 mm on a 100 mm VAS scale and pain frequency of at least 1 episode per week over the preceding 8 weeks will be recruited. In accordance to the specific Rome III criteria for inclusion, FAP is defined as a variable combination of chronic or recurrent gastrointestinal symptoms not explained by structural or biochemical abnormalities. A study questionnaire to record pain and other gastrointestinal symptoms will be used. One-hundred and six (106) Subjects will be randomized to receive either dietary supplementation with L. reuteri DSM 17938 (2 chewable tablets with breakfast), or the same number of comparable placebo tablets, 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 by the GSRS (Gastrointestinal Symptom Rating Score). Subjects/caregivers will be instructed to maintain the usual diet throughout the study, but not to consume other probiotics (foods or supplements) during the entire study period. The symptoms diary will be completed daily by the parents and will report information on the frequency of pain episodes, location of pain, presence or absence of associated symptoms, need to take medication for pain and interference with normal activities. The intensity of the symptoms will be assessed by using the Wong-Baker Faces scale.

Conditions

• Functional Abdominal Pain (FAP) in Children

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L. reuteri DSM 17938 chewable tablets	2 chewable tablets with breakfast for 4 weeks
DIETARY_SUPPLEMENT	Placebo chewable tablets	2 chewable tablets with breakfast for 4 weeks

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-11-01
• Last updated: 2016-02-23

Locations

3 sites across 3 countries: Greece, Poland, Slovenia