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

U

University of Bari

Status

Completed

Conditions

Functional Abdominal Pain

Treatments

Dietary Supplement: Lactobacillus GG (probiotic )
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00876291
UB2712

Details and patient eligibility

About

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.

Enrollment

140 patients

Sex

All

Ages

4 to 14 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

140 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
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)
Treatment:
Dietary Supplement: Placebo
Probiotic
Active Comparator group
Description:
LGG capsules: each cp containing 3 × 109 colony forming units, CFU
Treatment:
Dietary Supplement: Lactobacillus GG (probiotic )

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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