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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus GG and Smectite | Experimental | Children received:
|
|
| Lactobacillus GG and Placebo | Placebo Comparator | Children received:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smectite | Dietary 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatrics, The Medical University of Warsaw | Warsaw | Warsaw | 01-183 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18493225 | Background | Guarino A, Albano F, Ashkenazi S, Gendrel D, Hoekstra JH, Shamir R, Szajewska H; ESPGHAN/ESPID Evidence-Based Guidelines for the Management of Acute Gastroenteritis in Children in Europe Expert Working Group. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe: executive summary. J Pediatr Gastroenterol Nutr. 2008 May;46(5):619-21. doi: 10.1097/MPG.0b013e31816e219e. No abstract available. | |
| 9553803 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lactobacillus GG and Smectite | Children received:
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. 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 |
| FG001 | Lactobacillus GG and Placebo | Children received:
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. 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lactobacillus GG and Smectite | Children received:
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. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Median | Inter-Quartile Range | days | counted in days during 7days |
|
7days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lactobacillus GG and Smectite | Children received:
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. 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 |
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A potential limitation of our study is the lack of perfect blinding. Patients received smectite or placebo in identical packages from the hospital pharmacy. After being dissolved in water, they were of different colors.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hanna Szajewska, Malgorzata Pieścik-Lech | The Medical University of Warsaw | +48-22-45-23-309 | hania@ipgate.pl |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C033214 | Smectite |
| C016752 | smecta |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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|
| Placebo | Dietary 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 GG | Dietary 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 |
|
|
| 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 |
| Background |
| Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998 Feb 17;39(3):237-8. doi: 10.1016/s0168-1605(97)00136-0. No abstract available. |
| 17402990 | Background | Szajewska H, Skorka A, Ruszczynski M, Gieruszczak-Bialek D. Meta-analysis: Lactobacillus GG for treating acute diarrhoea in children. Aliment Pharmacol Ther. 2007 Apr 15;25(8):871-81. doi: 10.1111/j.1365-2036.2007.03282.x. |
| 16393300 | Background | Szajewska H, Dziechciarz P, Mrukowicz J. Meta-analysis: Smectite in the treatment of acute infectious diarrhoea in children. Aliment Pharmacol Ther. 2006 Jan 15;23(2):217-27. doi: 10.1111/j.1365-2036.2006.02760.x. |
| BG001 | Lactobacillus GG and Placebo | Children received:
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. 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 |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lactobacillus GG and Placebo |
Children received:
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. 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 |
|
|
|
| Secondary | Frequency of Loose Stools, | number of loose stools during 7 days | Posted | Median | Inter-Quartile Range | number of loose stools during 7days | number of loose stools during 7 days |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | Units on a scale | day 4-th |
|
|
|
| Secondary | Need for Antibiotic Therapy, | need for antibiotic therapy because of diarrhea | Posted | Number | participants | yes/no, for 7days |
|
|
|
| Secondary | Vomiting | If the child vomiting after randomization (yes/no) | Posted | Number | participants | yes/no, for 7days |
|
|
|
| Secondary | Vomiting | How many times the child was vomiting (during the study) | Posted | Median | Inter-Quartile Range | vomiting episodes | how many times for 7days |
|
|
|
| Secondary | Diarrhea Recurrence | If the was a diarrhea recurrence during 7days | Posted | Number | participants | 7 days |
|
|
|
| Secondary | Tolerance of Products | tolerance of products (whether the child took medicaments), | Posted | Number | participants | 7days |
|
|
|
| Secondary | Need for Hospitalization | If the child need to hospitalized | Posted | Number | participants | 7 days |
|
|
|
| Secondary | Need for Intravenous Therapy | need for intravenous rehydration therapy (yes/no) | Posted | Number | participants | yes/no, for 7days |
|
|
|
| Secondary | Duration of Intravenous Therapy | need for intravenous rehydration therapy (how long if needed) | Posted | Median | Inter-Quartile Range | days | 7days |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Lactobacillus GG and Placebo | Children received:
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. 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 | 0 | 37 | 0 | 37 |
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