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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
Enrollment 88

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 44 44
Completed 44 37
Not Completed 0 7
Reason Not Completed
Lost to Follow-up             0             7
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 44 44 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 44 participants 44 participants 88 participants
17.5
(10.0 to 22.5)
18
(11 to 30)
18
(10 to 23)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
<=18 years
44
 100.0%
44
 100.0%
88
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Female
23
  52.3%
15
  34.1%
38
  43.2%
Male
21
  47.7%
29
  65.9%
50
  56.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Poland Number Analyzed 44 participants 44 participants 88 participants
44 44 88
1.Primary Outcome
Title Duration of Diarrhea
Hide Description 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).
Time Frame counted in days during 7days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 44 37
Median (Inter-Quartile Range)
Unit of Measure: days
2
(1 to 3)
2
(1 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactobacillus GG and Smectite
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The differences between the study groups were considered significant when the P value was <0.05.
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Frequency of Loose Stools,
Hide Description number of loose stools during 7 days
Time Frame number of loose stools during 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 44 37
Median (Inter-Quartile Range)
Unit of Measure: number of loose stools during 7days
10.5
(5 to 21)
10
(5 to 15)
3.Secondary Outcome
Title Consistency of Stools
Hide Description

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.

Time Frame day 4-th
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 44 37
Median (Inter-Quartile Range)
Unit of Measure: Units on a scale
5
(3 to 6)
4
(0 to 5)
4.Secondary Outcome
Title Need for Antibiotic Therapy,
Hide Description need for antibiotic therapy because of diarrhea
Time Frame yes/no, for 7days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 44 37
Measure Type: Number
Unit of Measure: participants
0 0
5.Secondary Outcome
Title Vomiting
Hide Description If the child vomiting after randomization (yes/no)
Time Frame yes/no, for 7days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 44 37
Measure Type: Number
Unit of Measure: participants
9 11
6.Secondary Outcome
Title Vomiting
Hide Description How many times the child was vomiting (during the study)
Time Frame how many times for 7days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 44 37
Median (Inter-Quartile Range)
Unit of Measure: vomiting episodes
0
(0 to 1)
0
(0 to 0)
7.Secondary Outcome
Title Diarrhea Recurrence
Hide Description If the was a diarrhea recurrence during 7days
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 44 37
Measure Type: Number
Unit of Measure: participants
3 3
8.Secondary Outcome
Title Tolerance of Products
Hide Description tolerance of products (whether the child took medicaments),
Time Frame 7days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 44 37
Measure Type: Number
Unit of Measure: participants
34 32
9.Secondary Outcome
Title Need for Hospitalization
Hide Description If the child need to hospitalized
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 44 37
Measure Type: Number
Unit of Measure: participants
34 31
10.Secondary Outcome
Title Need for Intravenous Therapy
Hide Description need for intravenous rehydration therapy (yes/no)
Time Frame yes/no, for 7days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 44 37
Measure Type: Number
Unit of Measure: participants
23 25
11.Secondary Outcome
Title Duration of Intravenous Therapy
Hide Description need for intravenous rehydration therapy (how long if needed)
Time Frame 7days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 44 37
Median (Inter-Quartile Range)
Unit of Measure: days
1
(0 to 1)
1
(0 to 3)
Time Frame 7days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Hide Arm/Group Description

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

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

All-Cause Mortality
Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/37 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lactobacillus GG and Smectite Lactobacillus GG and Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/37 (0.00%) 
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.
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