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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01657032
First received: July 5, 2012
Last updated: February 14, 2014
Last verified: January 2010
  Purpose

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).


Condition Intervention Phase
Diarrhea
Dietary Supplement: Smectite
Dietary Supplement: Placebo
Dietary Supplement: Lactobacillus GG
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis: A Double Blind Randomized, Placebo- Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • Duration of Diarrhea [ Time Frame: counted in days during 7days ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Frequency of Loose Stools, [ Time Frame: number of loose stools during 7 days ] [ Designated as safety issue: Yes ]
    number of loose stools during 7 days

  • Consistency of Stools [ Time Frame: day 4-th ] [ Designated as safety issue: Yes ]

    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.


  • Need for Antibiotic Therapy, [ Time Frame: yes/no, for 7days ] [ Designated as safety issue: Yes ]
    need for antibiotic therapy because of diarrhea

  • Vomiting [ Time Frame: yes/no, for 7days ] [ Designated as safety issue: Yes ]
    If the child vomiting after randomization (yes/no)

  • Vomiting [ Time Frame: how many times for 7days ] [ Designated as safety issue: Yes ]
    How many times the child was vomiting (during the study)

  • Diarrhea Recurrence [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    If the was a diarrhea recurrence during 7days

  • Tolerance of Products [ Time Frame: 7days ] [ Designated as safety issue: Yes ]
    tolerance of products (whether the child took medicaments),

  • Need for Hospitalization [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    If the child need to hospitalized

  • Need for Intravenous Therapy [ Time Frame: yes/no, for 7days ] [ Designated as safety issue: Yes ]
    need for intravenous rehydration therapy (yes/no)

  • Duration of Intravenous Therapy [ Time Frame: 7days ] [ Designated as safety issue: Yes ]
    need for intravenous rehydration therapy (how long if needed)


Enrollment: 88
Study Start Date: August 2010
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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: 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 Name: glucose
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 Name: Dicoflor 30

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.

  Eligibility

Ages Eligible for Study:   3 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657032

Locations
Poland
Department of Paediatrics, The Medical University of Warsaw
Warsaw, Poland, 01-183
Sponsors and Collaborators
Medical University of Warsaw
  More Information

Publications:
Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01657032     History of Changes
Other Study ID Numbers: KB2010
Study First Received: July 5, 2012
Results First Received: November 20, 2013
Last Updated: February 14, 2014
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:
diarrhea
probiotics
diosmectite

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014