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Trial record 1 of 1 for:    9553803 [PUBMED-IDS]
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Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis

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ClinicalTrials.gov Identifier: NCT01657032
Recruitment Status : Completed
First Posted : August 3, 2012
Results First Posted : April 1, 2014
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diarrhea
Interventions: Dietary Supplement: Smectite
Dietary Supplement: Placebo
Dietary Supplement: Lactobacillus GG

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

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.

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

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

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


Participant Flow:   Overall Study
    Lactobacillus GG and Smectite   Lactobacillus GG and Placebo
STARTED   44   44 
COMPLETED   44   37 
NOT COMPLETED   0   7 
Lost to Follow-up                0                7 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

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.

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

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

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

Total Total of all reporting groups

Baseline Measures
   Lactobacillus GG and Smectite   Lactobacillus GG and Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   44   88 
Age 
[Units: Months]
Median (Inter-Quartile Range)
 17.5 
 (10.0 to 22.5) 
 18 
 (11 to 30) 
 18 
 (10 to 23) 
Age 
[Units: Participants]
     
<=18 years   44   44   88 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   23   15   38 
Male   21   29   50 
Region of Enrollment 
[Units: Participants]
     
Poland   44   44   88 


  Outcome Measures

1.  Primary:   Duration of Diarrhea   [ Time Frame: counted in days during 7days ]

2.  Secondary:   Frequency of Loose Stools,   [ Time Frame: number of loose stools during 7 days ]

3.  Secondary:   Consistency of Stools   [ Time Frame: day 4-th ]

4.  Secondary:   Need for Antibiotic Therapy,   [ Time Frame: yes/no, for 7days ]

5.  Secondary:   Vomiting   [ Time Frame: yes/no, for 7days ]

6.  Secondary:   Vomiting   [ Time Frame: how many times for 7days ]

7.  Secondary:   Diarrhea Recurrence   [ Time Frame: 7 days ]

8.  Secondary:   Tolerance of Products   [ Time Frame: 7days ]

9.  Secondary:   Need for Hospitalization   [ Time Frame: 7 days ]

10.  Secondary:   Need for Intravenous Therapy   [ Time Frame: yes/no, for 7days ]

11.  Secondary:   Duration of Intravenous Therapy   [ Time Frame: 7days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Hanna Szajewska, Malgorzata Pieścik-Lech
Organization: The Medical University of Warsaw
phone: +48-22-45-23-309
e-mail: hania@ipgate.pl


Publications:

Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01657032     History of Changes
Other Study ID Numbers: KB2010
First Submitted: July 5, 2012
First Posted: August 3, 2012
Results First Submitted: November 20, 2013
Results First Posted: April 1, 2014
Last Update Posted: April 1, 2014