Bifidobacteria In Children With Abdominal Pain-Associated Functional Gastrointestinal Disorders

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University

Criteria

Inclusion Criteria:

• Age 4-18years;

• Diagnosis of FD and IBS pain according to the Rome III criteria

• All parents or legal tutors must sign an informed consent document indicating their awareness of the investigational nature of this study.

Exclusion Criteria:

• Taking any other type of probiotic in the 2 months prior to enrollment

• Presence of intestinal motility disorders

• Presence of any other significant medical condition

• Presence of previous abdominal surgery

• Inability or unwillingness to give informed consent