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

Medical University of Warsaw88 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diarrhea

Interventions

SmectiteDIETARY_SUPPLEMENT

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.

PlaceboDIETARY_SUPPLEMENT

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.

Lactobacillus GGDIETARY_SUPPLEMENT

All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Paediatrics, The Medical University of Warsaw

Warsaw, Warsaw, Poland

Outcomes

Primary Outcomes

Duration of Diarrhea

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).

Time frame: counted in days during 7days

Secondary Outcomes

Frequency of Loose Stools,

number of loose stools during 7 days

Time frame: number of loose stools during 7 days

Consistency of Stools

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.

Time frame: day 4-th

Need for Antibiotic Therapy,

need for antibiotic therapy because of diarrhea

Time frame: yes/no, for 7days

Vomiting

If the child vomiting after randomization (yes/no)

Time frame: yes/no, for 7days

Vomiting

How many times the child was vomiting (during the study)

Time frame: how many times for 7days

Data from ClinicalTrials.gov

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