Trials / Completed
CompletedNCT00876291
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- University of Bari · Academic / Other
- Sex
- All
- Age
- 4 Years – 14 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2004-12-01
- Primary completion
- 2007-12-01
- Completion
- 2008-08-01
- First posted
- 2009-04-06
- Last updated
- 2011-02-01
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00876291. Inclusion in this directory is not an endorsement.