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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Medical University of Warsaw.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01657032
First received: July 5, 2012
Last updated: August 2, 2012
Last verified: January 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • duration of diarrhea [ Time Frame: counted in hours for 7days ] [ Designated as safety issue: Yes ]
    The primary outcome measure is duration of diarrhea (counted in hours; 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 per day, for 7days ] [ Designated as safety issue: Yes ]
    number of stools per day

  • consistency of stools [ Time Frame: 7days ] [ Designated as safety issue: Yes ]
    consistency of stools using Bristool Stool Scale Form

  • 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)

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


Estimated Enrollment: 88
Study Start Date: August 2010
Estimated Study Completion Date: September 2012
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657032

Contacts
Contact: Małgorzata MP Pieścik-Lech, doctor +48501510232 gosik81@wp.pl
Contact: Hanna HS Szajewska, Professor +484523309 hania@ipgate.pl

Locations
Poland
Department of Paediatrics, The Medical University of Warsaw Recruiting
Warsaw, Poland, 01-183
Contact: Małogrzata MP Pieścik-Lech, doctor     +48501510232     gosik81@wp.pl    
Contact: Hanna HS Szajewska, professor     +48224523309     hania@ipgate.pl    
Principal Investigator: Hanna HS Szajewska, professor            
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
Last Updated: August 2, 2012
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 May 23, 2013