NCT01657032

Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis

Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis: A Double Blind Randomized, Placebo- Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 3 Months – 5 Years
• Healthy volunteers: Not accepted

Summary

Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of both LGG and smectite in management of children with acute gastroenteritis (AGE).

Detailed description

ESPGHAN agreed to use probiotics, with proven efficacy, and smectite in treatment of AGE as an adjunct to standard rehydration therapy. Among probiotics Lactobacillus GG were found to be beneficial in meta-analyses. Treatment with LGG was associated with a significant reduction in diarrhea duration. A recent review systematically evaluated the efficacy of smectite in treating acute infections diarrhea in infants and children.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Smectite	Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
DIETARY_SUPPLEMENT	Placebo	Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
DIETARY_SUPPLEMENT	Lactobacillus GG	All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2012-08-03
• Last updated: 2014-04-01
• Results posted: 2014-04-01

Locations

1 site across 1 country: Poland