Diarrhea Clinical Trial
Official title:
Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis: A Double Blind Randomized, Placebo- Controlled Trial
Verified date | January 2010 |
Source | Medical University of Warsaw |
Contact | n/a |
Is FDA regulated | No |
Health authority | Poland: Ethics Committee |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 88 |
Est. completion date | October 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Months to 5 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Poland | Department of Paediatrics, The Medical University of Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
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. — View Citation
Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998 Feb 17;39(3):237-8. — View 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. — View Citation
Szajewska H, Skórka 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). | counted in days during 7days | Yes |
Secondary | Frequency of Loose Stools, | number of loose stools during 7 days | number of loose stools during 7 days | Yes |
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. |
day 4-th | Yes |
Secondary | Need for Antibiotic Therapy, | need for antibiotic therapy because of diarrhea | yes/no, for 7days | Yes |
Secondary | Vomiting | If the child vomiting after randomization (yes/no) | yes/no, for 7days | Yes |
Secondary | Vomiting | How many times the child was vomiting (during the study) | how many times for 7days | Yes |
Secondary | Diarrhea Recurrence | If the was a diarrhea recurrence during 7days | 7 days | Yes |
Secondary | Tolerance of Products | tolerance of products (whether the child took medicaments), | 7days | Yes |
Secondary | Need for Hospitalization | If the child need to hospitalized | 7 days | Yes |
Secondary | Need for Intravenous Therapy | need for intravenous rehydration therapy (yes/no) | yes/no, for 7days | Yes |
Secondary | Duration of Intravenous Therapy | need for intravenous rehydration therapy (how long if needed) | 7days | Yes |
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