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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01657032
Other study ID # KB2010
Secondary ID
Status Completed
Phase Phase 4
First received July 5, 2012
Last updated February 14, 2014
Start date August 2010
Est. completion date October 2012

Study information

Verified date January 2010
Source Medical University of Warsaw
Contact n/a
Is FDA regulated No
Health authority Poland: Ethics Committee
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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.
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

Locations

Country Name City State
Poland Department of Paediatrics, The Medical University of Warsaw Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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

Outcome

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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