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

Primary Purpose

Diarrhea

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Smectite
Placebo
Lactobacillus GG
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring diarrhea, probiotics, diosmectite

Eligibility Criteria

3 Months - 5 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Department of Paediatrics, The Medical University of Warsaw

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus GG and Smectite

Lactobacillus GG and Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2012
Last Updated
February 14, 2014
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT01657032
Brief Title
Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis
Official Title
Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis: A Double Blind Randomized, Placebo- Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
diarrhea, probiotics, diosmectite

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus GG and Smectite
Arm Type
Experimental
Arm 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
Arm Title
Lactobacillus GG and Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Smectite
Other Intervention Name(s)
Smecta
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
glucose
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus GG
Other Intervention Name(s)
Dicoflor 30
Intervention Description
All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite
Primary Outcome Measure Information:
Title
Duration of Diarrhea
Description
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 Outcome Measure Information:
Title
Frequency of Loose Stools,
Description
number of loose stools during 7 days
Time Frame
number of loose stools during 7 days
Title
Consistency of Stools
Description
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
Title
Need for Antibiotic Therapy,
Description
need for antibiotic therapy because of diarrhea
Time Frame
yes/no, for 7days
Title
Vomiting
Description
If the child vomiting after randomization (yes/no)
Time Frame
yes/no, for 7days
Title
Vomiting
Description
How many times the child was vomiting (during the study)
Time Frame
how many times for 7days
Title
Diarrhea Recurrence
Description
If the was a diarrhea recurrence during 7days
Time Frame
7 days
Title
Tolerance of Products
Description
tolerance of products (whether the child took medicaments),
Time Frame
7days
Title
Need for Hospitalization
Description
If the child need to hospitalized
Time Frame
7 days
Title
Need for Intravenous Therapy
Description
need for intravenous rehydration therapy (yes/no)
Time Frame
yes/no, for 7days
Title
Duration of Intravenous Therapy
Description
need for intravenous rehydration therapy (how long if needed)
Time Frame
7days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Paediatrics, The Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
01-183
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18493225
Citation
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.
Results Reference
background
PubMed Identifier
9553803
Citation
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.
Results Reference
background
PubMed Identifier
17402990
Citation
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.
Results Reference
background
PubMed Identifier
16393300
Citation
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.
Results Reference
background

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

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