Trial Outcomes & Findings for Study to Investigate the Potential of Probiotics in Yogurt (NCT NCT00492583)
NCT ID: NCT00492583
Last Updated: 2011-08-17
Results Overview
Outcome measure, "number of days children are out of school sick" was measured for the entire population
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
182 participants
Primary outcome timeframe
90 days
Results posted on
2011-08-17
Participant Flow
Participant milestones
| Measure |
Placebo
|
Bifidobacterium Lactis (BB-12)
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
87
|
|
Overall Study
COMPLETED
|
95
|
87
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate the Potential of Probiotics in Yogurt
Baseline characteristics by cohort
| Measure |
Placebo
n=95 Participants
|
Bifidobacterium Lactis (BB-12)
n=87 Participants
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
95 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
182 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/Gender, Customized
Female
|
36 participants
n=5 Participants
|
43 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
50 participants
n=5 Participants
|
34 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
95 participants
n=5 Participants
|
87 participants
n=7 Participants
|
182 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysOutcome measure, "number of days children are out of school sick" was measured for the entire population
Outcome measures
| Measure |
Placebo
n=95 Participants
|
Bifidobacterium Lactis (BB-12)
n=87 Participants
|
|---|---|---|
|
Number of Days Children Are Out of School Sick
|
2.51 days per 100 person days
|
2.82 days per 100 person days
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Bifidobacterium Lactis (BB-12)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=95 participants at risk
|
Bifidobacterium Lactis (BB-12)
n=87 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
3/95 • Number of events 3
|
2.3%
2/87 • Number of events 2
|
|
General disorders
Pyrexia
|
0.00%
0/95
|
1.1%
1/87 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis (Diaper)
|
3.2%
3/95 • Number of events 3
|
0.00%
0/87
|
|
Gastrointestinal disorders
Vomiting & Cough
|
3.2%
3/95 • Number of events 3
|
0.00%
0/87
|
|
Eye disorders
Hordeolum
|
1.1%
1/95 • Number of events 1
|
0.00%
0/87
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place