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

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

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).

Study Overview

• Status: Completed
• Conditions: Diarrhea
• Intervention / Treatment: Dietary supplement: Smectite; Dietary supplement: Lactobacillus GG; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-183
    • Department of Paediatrics, The Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus GG and Smectite; 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	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.; Other Names: Smecta; Dietary supplement: 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; Other Names: Dicoflor 30
Placebo Comparator: Lactobacillus GG and Placebo; 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	Dietary supplement: 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; Other Names: Dicoflor 30; Dietary supplement: 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.; Other Names: glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Loose Stools,	number of loose stools during 7 days	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.	day 4-th
Need for Antibiotic Therapy,	need for antibiotic therapy because of diarrhea	yes/no, for 7days
Vomiting	If the child vomiting after randomization (yes/no)	yes/no, for 7days
Vomiting	How many times the child was vomiting (during the study)	how many times for 7days
Diarrhea Recurrence	If the was a diarrhea recurrence during 7days	7 days
Tolerance of Products	tolerance of products (whether the child took medicaments),	7days
Need for Hospitalization	If the child need to hospitalized	7 days
Need for Intravenous Therapy	need for intravenous rehydration therapy (yes/no)	yes/no, for 7days
Duration of Intravenous Therapy	need for intravenous rehydration therapy (how long if needed)	7days

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (Estimate): August 3, 2012

Study Record Updates

• Last Update Posted (Estimate): April 1, 2014
• Last Update Submitted That Met QC Criteria: February 14, 2014
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: diarrhea; probiotics; diosmectite
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Diarrhea; Gastroenteritis
• Other Study ID Numbers: KB2010