A Multicentre, Randomised, Double-Blind, Placebo Controlled, Crossover Trial On The Efficacy Of A Mixture Of Three Bifidobacteria In Children With Abdominal Pain-Associated Functional Gastrointestinal Disorders

NCT02566876 Phase 4 COMPLETED

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.

Details

Lead sponsor	Federico II University
Phase	Phase 4
Status	COMPLETED
Enrolment	73
Start date	2013-12
Completion	2015-09

Conditions

• Irritable Bowel Syndrome
• Dyspepsia Chronic

Interventions

• Mixture of three Bifidobacteria

Primary outcomes

• Abdominal Pain Frequency — 16 weeks from the enrollment
  Score ranges from 0 (never) to 5 (every day)

Countries

Italy