Probiotic for the Prevention of Functional Disorders in Childhood
A Randomized Controlled Trial of Lactobacillus Rhamnosus Strain GG for The Prevention of Functional Abdominal Pain Children After Acute Gastroenteritis
2 other identifiers
interventional
400
1 country
1
Brief Summary
The present study has several aims:
- 1.Establish whether Lactobacillus Rhamnosus Strain GG is able to prevent the onset of IBS in a high risk group of children enrolled after an acute gastroenteritis (the study has been powered to this aim).
- 2.Establish whether Lactobacillus Rhamnosus Strain GG is able to stabilize the intestinal microbiota after an acute gastroenteritis.
- 3.Define the intestinal microbiota of children following an acute gastroenteritis and identify, if possible, a modification of the microbiota that can predict the emergence of Irritable Bowel Syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2012
CompletedFirst Posted
Study publicly available on registry
August 23, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedAugust 23, 2012
August 1, 2012
1.8 years
August 16, 2012
August 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevention of Abdominal pain
Primary outcome will be the incidence in IBS in children receiving LGG as compared to those receiving placebo. We have chosen pain as the primary outcome measure, in line with the proposed points-toconsider for IBS trials (Corazziari E. Consensus report: Clinical trial guidelines for pharmacological treatment of irritable bowel syndrome. Aliment Pharmcol Ther 2003;18:569). IBS or chronic abdominal pain will be diagnosed and categorised according to ROME III criteria (Rasquin A, Di Lorenzo C, Forbes D, et al. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006;130).
18 months
Secondary Outcomes (3)
Incidence of IBS
6 months
Children's health
24 months
Intestinal microbiota
24 months
Study Arms (2)
Lactobacillus Rhamnosus Strain GG
ACTIVE COMPARATORLGG (6 × 109 colony forming units)
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Lactobacillus Rhamnosus Strain GG
Eligibility Criteria
You may qualify if:
- Children of 3 - 16 years of age;
- Either sex.
You may not qualify if:
- Chronic disease,
- Clinical history of abdominal pain history suggestive for functional dyspepsia/aerophagia/abdominal migraine
- Growth failure,
- Alarm signs of organic conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinica Pediatrica
Bari, Apulia, 70125, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruggiero Francavilla
University of Bari
- PRINCIPAL INVESTIGATOR
Ruggiero FRANCAVILLA
DEPARTMENT OF BIOMEDICINA ETA' EVOLUTIVA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 16, 2012
First Posted
August 23, 2012
Study Start
September 1, 2012
Primary Completion
July 1, 2014
Study Completion
September 1, 2014
Last Updated
August 23, 2012
Record last verified: 2012-08