Trial | NCT00876291  Report issue

Title

Efficacy of Lactobacillus GG (LGG) in Children With Abdominal Pain
The Use of Lactobacillus gg in Functional Abdominal Pain in Children: a Double-blind Randomized Control Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    140
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 Started
Dec 31
2004
Primary Completion
Dec 31
2007
Study Completion
Aug 31
2008
Last Update
Feb 01
2011
Estimate

Dietary Supplement Lactobacillus GG (probiotic )

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

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)

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)

Probiotic Active Comparator

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

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.
No Results Posted