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Bifidobacteria In Children With Abdominal Pain-Associated Functional Gastrointestinal Disorders

CompletedPhase 4NCT02566876
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
Conditions
Interventions
  • Drug: Mixture of three Bifidobacteria
Sponsor
Federico II University
Start date
2013-12
Primary completion
2015-07
Sex
All
Age range
from 4 Years to 18 Years
Results posted
No results posted in this snapshot
Countries
Italy
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02566876