Clinical trial NCT00876291: Efficacy of Lactobacillus GG (LGG) in Children With Abdominal Pain
Official title: The Use of Lactobacillus gg in Functional Abdominal Pain in Children: a Double-blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Abdominal Pain
Lead sponsor: University of Bari
Sponsor class: OTHER
Collaborators: name: Clinica PEdiatrica Ospedale San Paolo Bari Italy
First posted: 2009-04-06
Enrollment: 140
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention.
timeFrame: 12 weeks and 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Clinica Pediatrica
Study officials:
affiliation: University of Bari
name: Ruggiero Francavilla, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.