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

Medical University of Warsaw

Status and phase: Completed; Phase 4

Conditions: Diarrhea

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Smectite; Dietary Supplement: Lactobacillus GG

Study type: Interventional

Funder types: Other

Identifiers

NCT01657032

KB2010

Details and patient eligibility

About

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).

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 3 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children < 5 years old
• diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1 day but < 5 days
• inform consent sing

Exclusion criteria

• diarrhea < 1 or > 5 days,
• a recent history of diarrhea indicated either by parents/guardian or hospital case notes,
• underlying chronic gastrointestinal disease,
• undernutrition (weight/height ratio below the 5th percentile),
• systematic infection,
• immune defects or immunosuppressive treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

Lactobacillus GG and Smectite

Experimental group

Description:

Children received: * LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and * smectite, dose 3 g, once daily orally until diarrhea stopped

Treatment:

Dietary Supplement: Lactobacillus GG

Dietary Supplement: Smectite

Lactobacillus GG and Placebo

Placebo Comparator group

Description:

Children received: * LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and * placebo (glucose), dose 3 g, once daily orally until diarrhea stopped

Treatment:

Dietary Supplement: Lactobacillus GG

Dietary Supplement: Placebo