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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diarrhea

Intervention / Treatment
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* Dietary Supplement: Smectite
* Dietary Supplement: Placebo
* Dietary Supplement: Lactobacillus GG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus GG and Smectite<br>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 | Dietary Supplement: Smectite<br>* 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.<br>* Other names: Smecta;Dietary Supplement: Lactobacillus GG<br>* All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite<br>* Other names: Dicoflor 30;|
| Placebo Comparator: Lactobacillus GG and Placebo<br>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 | Dietary Supplement: Placebo<br>* 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.<br>* Other names: glucose;Dietary Supplement: Lactobacillus GG<br>* All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite<br>* Other names: Dicoflor 30;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | counted in days during 7days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Loose Stools, | number of loose stools during 7 days | 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. | day 4-th | 
| Need for Antibiotic Therapy, | need for antibiotic therapy because of diarrhea | yes/no, for 7days | 
| Vomiting | If the child vomiting after randomization (yes/no) | yes/no, for 7days | 
| Vomiting | How many times the child was vomiting (during the study) | how many times for 7days | 
| Diarrhea Recurrence | If the was a diarrhea recurrence during 7days | 7 days | 
| Tolerance of Products | tolerance of products (whether the child took medicaments), | 7days | 
| Need for Hospitalization | If the child need to hospitalized | 7 days | 
| Need for Intravenous Therapy | need for intravenous rehydration therapy (yes/no) | yes/no, for 7days | 
| Duration of Intravenous Therapy | need for intravenous rehydration therapy (how long if needed) | 7days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diarrhea, probiotics, diosmectite