Clinical trial NCT01657032: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diarrhea
Keywords: diarrhea
probiotics
diosmectite
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 88
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Duration of Diarrhea
timeFrame: counted in days during 7days
Secondary outcomes:
measure: Frequency of Loose Stools,
timeFrame: number of loose stools during 7 days
measure: Consistency of Stools
timeFrame: day 4-th
measure: Need for Antibiotic Therapy,
timeFrame: yes/no, for 7days
measure: Vomiting
timeFrame: yes/no, for 7days
measure: Vomiting
timeFrame: how many times for 7days
measure: Diarrhea Recurrence
timeFrame: 7 days
measure: Tolerance of Products
timeFrame: 7days
measure: Need for Hospitalization
timeFrame: 7 days
measure: Need for Intravenous Therapy
timeFrame: yes/no, for 7days
measure: Duration of Intravenous Therapy
timeFrame: 7days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Paediatrics, The Medical University of Warsaw
Study officials:
References:
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.
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.
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.
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.