Trial Outcomes & Findings for Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis (NCT NCT01657032)
NCT ID: NCT01657032
Last Updated: 2014-04-01
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
88 participants
Primary outcome timeframe
counted in days during 7days
Results posted on
2014-04-01
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
|
Overall Study
COMPLETED
|
44
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
7
|
Baseline Characteristics
Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis
Baseline characteristics by cohort
| Measure |
Lactobacillus GG and Smectite
n=44 Participants
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
n=44 Participants
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
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.5 months
n=5 Participants
|
18 months
n=7 Participants
|
18 months
n=5 Participants
|
|
Age, Categorical
<=18 years
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
44 participants
n=5 Participants
|
44 participants
n=7 Participants
|
88 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: counted in days during 7daysThe 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).
Outcome measures
| Measure |
Lactobacillus GG and Smectite
n=44 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Duration of Diarrhea
|
2 days
Interval 1.0 to 3.0
|
2 days
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: number of loose stools during 7 daysnumber of loose stools during 7 days
Outcome measures
| Measure |
Lactobacillus GG and Smectite
n=44 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Frequency of Loose Stools,
|
10.5 number of loose stools during 7days
Interval 5.0 to 21.0
|
10 number of loose stools during 7days
Interval 5.0 to 15.0
|
SECONDARY outcome
Timeframe: day 4-thconsistency 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.
Outcome measures
| Measure |
Lactobacillus GG and Smectite
n=44 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Consistency of Stools
|
5 Units on a scale
Interval 3.0 to 6.0
|
4 Units on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: yes/no, for 7daysneed for antibiotic therapy because of diarrhea
Outcome measures
| Measure |
Lactobacillus GG and Smectite
n=44 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Need for Antibiotic Therapy,
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: yes/no, for 7daysIf the child vomiting after randomization (yes/no)
Outcome measures
| Measure |
Lactobacillus GG and Smectite
n=44 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Vomiting
|
9 participants
|
11 participants
|
SECONDARY outcome
Timeframe: how many times for 7daysHow many times the child was vomiting (during the study)
Outcome measures
| Measure |
Lactobacillus GG and Smectite
n=44 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Vomiting
|
0 vomiting episodes
Interval 0.0 to 1.0
|
0 vomiting episodes
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 7 daysIf the was a diarrhea recurrence during 7days
Outcome measures
| Measure |
Lactobacillus GG and Smectite
n=44 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Diarrhea Recurrence
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 7daystolerance of products (whether the child took medicaments),
Outcome measures
| Measure |
Lactobacillus GG and Smectite
n=44 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Tolerance of Products
|
34 participants
|
32 participants
|
SECONDARY outcome
Timeframe: 7 daysIf the child need to hospitalized
Outcome measures
| Measure |
Lactobacillus GG and Smectite
n=44 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Need for Hospitalization
|
34 participants
|
31 participants
|
SECONDARY outcome
Timeframe: yes/no, for 7daysneed for intravenous rehydration therapy (yes/no)
Outcome measures
| Measure |
Lactobacillus GG and Smectite
n=44 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Need for Intravenous Therapy
|
23 participants
|
25 participants
|
SECONDARY outcome
Timeframe: 7daysneed for intravenous rehydration therapy (how long if needed)
Outcome measures
| Measure |
Lactobacillus GG and Smectite
n=44 Participants
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
n=37 Participants
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
|
|---|---|---|
|
Duration of Intravenous Therapy
|
1 days
Interval 0.0 to 1.0
|
1 days
Interval 0.0 to 3.0
|
Adverse Events
Lactobacillus GG and Smectite
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lactobacillus GG and Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Hanna Szajewska, Malgorzata Pieścik-Lech
The Medical University of Warsaw
Phone: +48-22-45-23-309
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place