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

NCT01657032 | Completed Phase 4 Results DMC

• 1 other identifier: KB2010
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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).

Conditions

Diarrhea

Keywords

diarrhea; probiotics; diosmectite

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Frequency of Loose Stools,

  number of loose stools during 7 days

• Consistency of Stools

  day 4-th

• Need for Antibiotic Therapy,

  yes/no, for 7days

• Vomiting

  yes/no, for 7days

• Vomiting

  how many times for 7days

Study Arms (2)

Lactobacillus GG and Smectite

EXPERIMENTAL

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; Dietary Supplement: Lactobacillus GG

Lactobacillus GG and Placebo

PLACEBO COMPARATOR

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: Placebo; Dietary Supplement: Lactobacillus GG

Interventions

Smectite DIETARY_SUPPLEMENT

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.

Also known as: Smecta

Lactobacillus GG and Smectite

Placebo DIETARY_SUPPLEMENT

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.

Also known as: glucose

Lactobacillus GG and Placebo

Lactobacillus GG DIETARY_SUPPLEMENT

All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite

Also known as: Dicoflor 30

Lactobacillus GG and Placebo; Lactobacillus GG and Smectite

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Paediatrics, The Medical University of Warsaw

Warsaw, Warsaw, 01-183, Poland

Location

Related 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. No abstract available.

  PMID: 18493225 BACKGROUND

• 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.

  PMID: 9553803 BACKGROUND

• 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.

  PMID: 17402990 BACKGROUND

• 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.

  PMID: 16393300 BACKGROUND

MeSH Terms

Conditions

Diarrhea

Interventions

Smectite; smecta; Glucose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Limitations and Caveats

A potential limitation of our study is the lack of perfect blinding. Patients received smectite or placebo in identical packages from the hospital pharmacy. After being dissolved in water, they were of different colors.

Results Point of Contact

• Title: Hanna Szajewska, Malgorzata Pieścik-Lech
• Organization: The Medical University of Warsaw

hania@ipgate.pl

+48-22-45-23-309

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: August 3, 2012
• Study Start: August 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 1, 2014
• Results First Posted: April 1, 2014

Record last verified: 2010-01

Locations

PL (1)