NCT00876291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
Last Updated

February 1, 2011

Status Verified

April 1, 2009

Enrollment Period

3 years

First QC Date

April 2, 2009

Last Update Submit

January 31, 2011

Conditions

Functional Abdominal Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Probiotic

ACTIVE COMPARATOR

LGG capsules: each cp containing 3 × 109 colony forming units, CFU

Dietary Supplement: Lactobacillus GG (probiotic )

Interventions

Lactobacillus GG (probiotic )DIETARY_SUPPLEMENT

LGG capsules: each cp containing 3 × 109 colony forming units, CFU

Probiotic
PlaceboDIETARY_SUPPLEMENT

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)

Placebo

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Pediatrica

Bari, 70100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 21078735DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ruggiero Francavilla, MD PhD

    University of Bari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 6, 2009

Study Start

December 1, 2004

Primary Completion

December 1, 2007

Study Completion

August 1, 2008

Last Updated

February 1, 2011

Record last verified: 2009-04

Locations

IT(1)