Efficacy of Lactobacillus GG (LGG) in Children With Abdominal Pain (LGGDAR)

The Use of Lactobacillus gg in Functional Abdominal Pain in Children: a Double-blind Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Functional Abdominal Pain
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Lactobacillus GG (probiotic )

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70100
    • Clinica Pediatrica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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)	Dietary supplement: Placebo; 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)
Active Comparator: Probiotic; LGG capsules: each cp containing 3 × 109 colony forming units, CFU	Dietary supplement: Lactobacillus GG (probiotic ); LGG capsules: each cp containing 3 × 109 colony forming units, CFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention.	12 weeks and 20 weeks

Collaborators and Investigators

• Sponsor: University of Bari
• Collaborators: Clinica PEdiatrica Ospedale San Paolo Bari Italy
• Investigators: Principal Investigator: ruggiero francavilla, Md PhD, University of Bari

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: April 2, 2009
• First Submitted That Met QC Criteria: April 3, 2009
• First Posted (Estimate): April 6, 2009

Study Record Updates

• Last Update Posted (Estimate): February 1, 2011
• Last Update Submitted That Met QC Criteria: January 31, 2011
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: UB2712

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No