Trial Outcomes & Findings for Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis (NCT NCT01773967)
NCT ID: NCT01773967
Last Updated: 2019-09-06
Results Overview
This is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources. Scores \>=9 indicate moderate-severe gastroenteritis. Higher is worse.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
971 participants
Primary outcome timeframe
14 days
Results posted on
2019-09-06
Participant Flow
Participant milestones
| Measure |
Lactobacillus Rhamnosus GG
LGG 10\^10 cfu PO bid x 5 days
LGG: LGG 10\^10 cfu PO BID X 5 days
|
Placebo
micro-crystalline cellulose PO bid x 5 days
micro-crystalline cellulose: 1 capsule PO bid x 5 days
|
|---|---|---|
|
Overall Study
STARTED
|
483
|
488
|
|
Overall Study
COMPLETED
|
468
|
475
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
Reasons for withdrawal
| Measure |
Lactobacillus Rhamnosus GG
LGG 10\^10 cfu PO bid x 5 days
LGG: LGG 10\^10 cfu PO BID X 5 days
|
Placebo
micro-crystalline cellulose PO bid x 5 days
micro-crystalline cellulose: 1 capsule PO bid x 5 days
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
13
|
Baseline Characteristics
Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Baseline characteristics by cohort
| Measure |
Lactobacillus Rhamnosus GG
n=483 Participants
LGG 10\^10 cfu PO bid x 5 days
LGG: LGG 10\^10 cfu PO BID X 5 days
|
Placebo
n=488 Participants
micro-crystalline cellulose PO bid x 5 days
micro-crystalline cellulose: 1 capsule PO bid x 5 days
|
Total
n=971 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
1.4 years
n=5 Participants
|
1.4 years
n=7 Participants
|
1.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
236 Participants
n=5 Participants
|
222 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
247 Participants
n=5 Participants
|
266 Participants
n=7 Participants
|
513 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
176 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
338 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
144 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
121 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
483 participants
n=5 Participants
|
488 participants
n=7 Participants
|
971 participants
n=5 Participants
|
|
Median Modified Vesikari Scale score at presentation
|
12 units on a scale
n=5 Participants
|
12 units on a scale
n=7 Participants
|
12 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysThis is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources. Scores \>=9 indicate moderate-severe gastroenteritis. Higher is worse.
Outcome measures
| Measure |
Lactobacillus Rhamnosus GG
n=468 Participants
LGG 10\^10 cfu PO bid x 5 days
LGG: LGG 10\^10 cfu PO BID X 5 days
|
Placebo
n=475 Participants
micro-crystalline cellulose PO bid x 5 days
micro-crystalline cellulose: 1 capsule PO bid x 5 days
|
|---|---|---|
|
Number of Participants With Modified Vesikari Scale Score >=9
|
55 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: 1 monthbacteremia caused by LGG
Outcome measures
| Measure |
Lactobacillus Rhamnosus GG
n=468 Participants
LGG 10\^10 cfu PO bid x 5 days
LGG: LGG 10\^10 cfu PO BID X 5 days
|
Placebo
n=475 Participants
micro-crystalline cellulose PO bid x 5 days
micro-crystalline cellulose: 1 capsule PO bid x 5 days
|
|---|---|---|
|
Number of Participants With LGG Bacteremia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 daysdiarrhea duration in hours after randomization
Outcome measures
| Measure |
Lactobacillus Rhamnosus GG
n=468 Participants
LGG 10\^10 cfu PO bid x 5 days
LGG: LGG 10\^10 cfu PO BID X 5 days
|
Placebo
n=475 Participants
micro-crystalline cellulose PO bid x 5 days
micro-crystalline cellulose: 1 capsule PO bid x 5 days
|
|---|---|---|
|
Diarrhea Duration
|
49.7 hours
Interval 18.8 to 86.4
|
50.9 hours
Interval 25.0 to 88.2
|
Adverse Events
Lactobacillus Rhamnosus GG
Serious events: 8 serious events
Other events: 55 other events
Deaths: 0 deaths
Placebo
Serious events: 13 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lactobacillus Rhamnosus GG
n=483 participants at risk
LGG 10\^10 cfu PO bid x 5 days
LGG: LGG 10\^10 cfu PO BID X 5 days
|
Placebo
n=488 participants at risk
micro-crystalline cellulose PO bid x 5 days
micro-crystalline cellulose: 1 capsule PO bid x 5 days
|
|---|---|---|
|
Gastrointestinal disorders
Worsening diarrhea
|
0.62%
3/483 • Number of events 3 • 35 days, long term follow up 1 year
|
0.82%
4/488 • Number of events 4 • 35 days, long term follow up 1 year
|
|
Gastrointestinal disorders
ileus
|
0.21%
1/483 • Number of events 1 • 35 days, long term follow up 1 year
|
0.20%
1/488 • Number of events 1 • 35 days, long term follow up 1 year
|
|
Nervous system disorders
seizure
|
0.21%
1/483 • Number of events 1 • 35 days, long term follow up 1 year
|
0.20%
1/488 • Number of events 1 • 35 days, long term follow up 1 year
|
|
Nervous system disorders
lethargy
|
0.21%
1/483 • Number of events 1 • 35 days, long term follow up 1 year
|
0.20%
1/488 • Number of events 1 • 35 days, long term follow up 1 year
|
|
Respiratory, thoracic and mediastinal disorders
lower respiratory infection
|
0.00%
0/483 • 35 days, long term follow up 1 year
|
0.41%
2/488 • Number of events 2 • 35 days, long term follow up 1 year
|
|
Gastrointestinal disorders
dehydration
|
0.21%
1/483 • Number of events 1 • 35 days, long term follow up 1 year
|
0.41%
2/488 • Number of events 2 • 35 days, long term follow up 1 year
|
|
Metabolism and nutrition disorders
metabolic acidosis
|
0.21%
1/483 • Number of events 1 • 35 days, long term follow up 1 year
|
0.00%
0/488 • 35 days, long term follow up 1 year
|
|
General disorders
fever
|
0.00%
0/483 • 35 days, long term follow up 1 year
|
0.20%
1/488 • Number of events 1 • 35 days, long term follow up 1 year
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/483 • 35 days, long term follow up 1 year
|
0.20%
1/488 • Number of events 1 • 35 days, long term follow up 1 year
|
Other adverse events
| Measure |
Lactobacillus Rhamnosus GG
n=483 participants at risk
LGG 10\^10 cfu PO bid x 5 days
LGG: LGG 10\^10 cfu PO BID X 5 days
|
Placebo
n=488 participants at risk
micro-crystalline cellulose PO bid x 5 days
micro-crystalline cellulose: 1 capsule PO bid x 5 days
|
|---|---|---|
|
Gastrointestinal disorders
other
|
8.3%
40/483 • Number of events 40 • 35 days, long term follow up 1 year
|
7.2%
35/488 • Number of events 35 • 35 days, long term follow up 1 year
|
|
Respiratory, thoracic and mediastinal disorders
other
|
3.1%
15/483 • Number of events 15 • 35 days, long term follow up 1 year
|
2.9%
14/488 • Number of events 14 • 35 days, long term follow up 1 year
|
Additional Information
Dr. David Schnadower
Cincinnati Children's Hospital Medical Center
Phone: 5138035526
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place