Back to resultsEfficacy of Lactobacillus GG (LGG) in Children With Abdominal Pain (LGGDAR)
Primary Purpose
Functional Abdominal Pain
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lactobacillus GG (probiotic )
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Functional Abdominal Pain
Eligibility Criteria
Inclusion Criteria:
- Patients were considered for study inclusion, if they were 4 - 12 years of age and had if they had a pain history of at least 12 weeks (which need not be consecutive) in the preceding 12 months suggestive for IBS or FAP with no structural or metabolic abnormalities to explain the symptoms and according to the Rome II diagnostic criteria valid at the time of the design of the study.
IBS was diagnosed in presence of an abdominal discomfort or pain with at least two of three features:
- relieved with defecation
- onset associated with a change in stool frequency
- onset associated with a change in the form (appearance) of the stool.
- FAP was diagnosed in presence of symptoms of
- Continuous (nearly continuous) abdominal pain
- No or only occasional relation of pain with physiological events (e.g. eating, menses)
- Some loss of daily functioning
- The pain is not feigned (e.g. malingering)
- The patient has insufficient criteria for other functional gastrointestinal disorders that would explain the abdominal pain.
Exclusion Criteria:
- Known concomitant psychiatric, neurological, metabolic, hepatic, renal, infectious, haematological, cardiovascular and pulmonary disease
- Treatment with antibiotics/probiotics in the last 2 months
- A pain history suggestive for functional dyspepsia or aerophagia or abdominal migrain
- Growth failure
- Gastroparesis
- Gastrointestinal obstructions/stricture
- Any disease that may affect bowel motility such as diabetes, connective disease or poorly controlled hypo/hyperthyrodism
- Previous abdominal surgery.
Sites / Locations
- Clinica Pediatrica
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Probiotic
Arm Description
placebo which consisted of capsules identical in taste and appearance to the active study product except for the absence of freeze-dried LGG (and cryoprotectants)
LGG capsules: each cp containing 3 × 109 colony forming units, CFU
Outcomes
Primary Outcome Measures
The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention.
Secondary Outcome Measures
Full Information
NCT ID
NCT00876291
First Posted
April 2, 2009
Last Updated
January 31, 2011
Sponsor
University of Bari
Collaborators
Clinica PEdiatrica Ospedale San Paolo Bari Italy
1. Study Identification
Unique Protocol Identification Number
NCT00876291
Brief Title
Efficacy of Lactobacillus GG (LGG) in Children With Abdominal Pain
Acronym
LGGDAR
Official Title
The Use of Lactobacillus gg in Functional Abdominal Pain in Children: a Double-blind Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bari
Collaborators
Clinica PEdiatrica Ospedale San Paolo Bari Italy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Even though most of the studies demonstrate efficacy, other studies do not support these observations. Few studies addresses the efficacy of probiotics in children with IBS. The goal of the present study was to determine whether oral administration of the probiotic Lactobacillus GG under randomized, double-blind, placebo-controlled conditions would improve symptoms of children with abdominal pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Abdominal Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo which consisted of capsules identical in taste and appearance to the active study product except for the absence of freeze-dried LGG (and cryoprotectants)
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
LGG capsules: each cp containing 3 × 109 colony forming units, CFU
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus GG (probiotic )
Intervention Description
LGG capsules: each cp containing 3 × 109 colony forming units, CFU
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
placebo which consisted of capsules identical in taste and appearance to the active study product except for the absence of freeze-dried LGG (and cryoprotectants)
Primary Outcome Measure Information:
Title
The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention.
Time Frame
12 weeks and 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients were considered for study inclusion, if they were 4 - 12 years of age and had if they had a pain history of at least 12 weeks (which need not be consecutive) in the preceding 12 months suggestive for IBS or FAP with no structural or metabolic abnormalities to explain the symptoms and according to the Rome II diagnostic criteria valid at the time of the design of the study.
IBS was diagnosed in presence of an abdominal discomfort or pain with at least two of three features:
relieved with defecation
onset associated with a change in stool frequency
onset associated with a change in the form (appearance) of the stool.
FAP was diagnosed in presence of symptoms of
Continuous (nearly continuous) abdominal pain
No or only occasional relation of pain with physiological events (e.g. eating, menses)
Some loss of daily functioning
The pain is not feigned (e.g. malingering)
The patient has insufficient criteria for other functional gastrointestinal disorders that would explain the abdominal pain.
Exclusion Criteria:
Known concomitant psychiatric, neurological, metabolic, hepatic, renal, infectious, haematological, cardiovascular and pulmonary disease
Treatment with antibiotics/probiotics in the last 2 months
A pain history suggestive for functional dyspepsia or aerophagia or abdominal migrain
Growth failure
Gastroparesis
Gastrointestinal obstructions/stricture
Any disease that may affect bowel motility such as diabetes, connective disease or poorly controlled hypo/hyperthyrodism
Previous abdominal surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruggiero Francavilla, MD PhD
Organizational Affiliation
University of Bari
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Pediatrica
City
Bari
ZIP/Postal Code
70100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21078735
Citation
Francavilla R, Miniello V, Magista AM, De Canio A, Bucci N, Gagliardi F, Lionetti E, Castellaneta S, Polimeno L, Peccarisi L, Indrio F, Cavallo L. A randomized controlled trial of Lactobacillus GG in children with functional abdominal pain. Pediatrics. 2010 Dec;126(6):e1445-52. doi: 10.1542/peds.2010-0467. Epub 2010 Nov 15.
Results Reference
derived
Learn more about this trial
Efficacy of Lactobacillus GG (LGG) in Children With Abdominal Pain
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