Bifidobacteria In Children With Abdominal Pain-Associated Functional Gastrointestinal Disorders
CompletedPhase 4NCT02566876
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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
- Irritable Bowel Syndrome
- Dyspepsia Chronic
- 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