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| Name | Class |
|---|---|
| Clinica PEdiatrica Ospedale San Paolo Bari Italy | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus GG (probiotic ) | Dietary Supplement | LGG capsules: each cp containing 3 × 109 colony forming units, CFU |
|
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Ruggiero Francavilla, MD PhD | University of Bari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Pediatrica | Bari | 70100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21078735 | Derived | 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. |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | 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) |
|
| D019602 |
| Food and Beverages |