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

Diarrhea Clinical Trial

Official title:

Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis: A Double Blind Randomized, Placebo- Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657032
• Other study ID #: KB2010
• 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

• Diarrhea
• Gastroenteritis

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