drugset / Trial / NCT02566876

Bifidobacteria In Children With Abdominal Pain-Associated Functional Gastrointestinal Disorders

NCT02566876 ↗

Phase 4 Completed 73 enrolled Federico II University
RandomizedCrossoverDouble-blindTreatment

Summary

Abdominal pain (AP)-associated functional gastrointestinal disorders (FGIDs), particularly Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), are common in pediatrics, and no safe and effective treatment is available. Although probiotics have shown promising results in adults, few studies have been published in children. The Bifidobacterium Infantis, Bifidobacterium Breve and Bifidobacterium Longum are the most important beneficial bacteria in children and represent 95% of the total bacterial population in the intestine of breastfed infant. Objectives: 1) To evaluate the effect of oral administration of a mixture of Bifidobacteria on the improvement of frequency and intensity of AP in children with FD and IBS. 2) To evaluate the effect of oral administration of a mixture of Bifidobacteria on quality of life in children with FD and IBS.

Timeline

Start
2013-12
Primary completion
2015-07
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bifidobacterium breve M-16V Other / unclassified 1e+09 cells Oral
Comparator Bifidobacterium infantis M-63 Other / unclassified 1e+09 cells Oral
Comparator Bifidobacterium longum BB536 Other / unclassified 3e+09 cells Oral