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

Study Overview
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Brief Summary
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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.

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

Conditions
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Functional Abdominal Pain

Intervention / Treatment
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* Dietary Supplement: Lactobacillus GG (probiotic )
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* 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)<br>|
| Active Comparator: Probiotic<br>LGG capsules: each cp containing 3 × 109 colony forming units, CFU | Dietary Supplement: Lactobacillus GG (probiotic )<br>* LGG capsules: each cp containing 3 × 109 colony forming units, CFU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |