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

Phase 4

Completed

Interventions: Dietary Supplement: Smectite
Dietary Supplement: Placebo
Dietary Supplement: Lactobacillus GG

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Lactobacillus GG and Smectite	Smectite	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
Lactobacillus GG and Smectite	Lactobacillus GG	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
Lactobacillus GG and Placebo	Placebo	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
Lactobacillus GG and Placebo	Lactobacillus GG	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

Primary Outcome Measures

Name	Time	Method
Duration of Diarrhea	counted in days during 7days	The primary outcome measure is duration of diarrhea (counted in days; from the first loose stool to the last one; end of diarrhea defined as last loose stool or at least 12hours without stool).

Secondary Outcome Measures

Name	Time	Method
Frequency of Loose Stools,	number of loose stools during 7 days	number of loose stools during 7 days
Consistency of Stools	day 4-th	consistency of stools using Bristool Stool Scale Form on day 4-th. (The Bristol stool scale form is a medical aid designed to classify the form of human faeces into seven categories. Type 1 Separate hard lumps, like nuts (hard to pass) Type 2 Sausage-shaped but lumpy Type 3 Like a sausage but with cracks on the surface Type 4 Like a sausage or snake, smooth and soft Type 5 Soft blobs with clear-cut edges Type 6 Fluffy pieces with ragged edges, a mushy stool Type 7 Watery, no solid pieces. Entirely liquid Types 1-2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing any excess liquid, and 5, 6 and 7 tending towards diarrhoea.
Need for Antibiotic Therapy,	yes/no, for 7days	need for antibiotic therapy because of diarrhea
Vomiting	how many times for 7days	How many times the child was vomiting (during the study)
Diarrhea Recurrence	7 days	If the was a diarrhea recurrence during 7days
Tolerance of Products	7days	tolerance of products (whether the child took medicaments),
Need for Hospitalization	7 days	If the child need to hospitalized
Need for Intravenous Therapy	yes/no, for 7days	need for intravenous rehydration therapy (yes/no)
Duration of Intravenous Therapy	7days	need for intravenous rehydration therapy (how long if needed)