Trial Outcomes & Findings for Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children (NCT NCT01652287)
NCT ID: NCT01652287
Last Updated: 2024-03-22
Results Overview
The primary outcome is to assess the safety of BB-12® yogurt when consumed by generally healthy children. To achieve this aim, data on adverse events will be collected from diaries; calls to the 24-hour advice line; and research assistant phone calls on days 6, 11, 15 and 180, ±2 days. All adverse events will be tabulated by type and charted over time.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
62 participants
Primary outcome timeframe
Days 0-180
Results posted on
2024-03-22
Participant Flow
Participant milestones
| Measure |
BB-12
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
|
Control
yogurt cultured with starter YF-L702
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
BB-12
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
|
Control
yogurt cultured with starter YF-L702
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children
Baseline characteristics by cohort
| Measure |
BB-12®
n=29 Participants
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
|
Control
n=31 Participants
yogurt cultured with starter YF-L702
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Parent's Marital Status
Divorced
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Total Household Income
$15,000-$30,000
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Total Household Income
$30,001-$75,000
|
6 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Total Household Income
$75,001-$100,000
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Total Household Income
$100,001-$150,000
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Total Household Income
>$150,000
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Age, Categorical
<=18 years
|
29 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Child Attends Daycare
Yes
|
20 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Child Attends Daycare
No
|
9 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Parent's Marital Status
Married/Living with partner
|
26 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Parent's Marital Status
Single
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Total Household Income
No response
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Smoker in Household-Yes
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Days 0-180The primary outcome is to assess the safety of BB-12® yogurt when consumed by generally healthy children. To achieve this aim, data on adverse events will be collected from diaries; calls to the 24-hour advice line; and research assistant phone calls on days 6, 11, 15 and 180, ±2 days. All adverse events will be tabulated by type and charted over time.
Outcome measures
| Measure |
BB-12®
n=29 Participants
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
|
Control
n=31 Participants
yogurt cultured with starter YF-L702
|
|---|---|---|
|
Number of Adverse Events
During intervention (day 0-10)
|
61 Number of AE reported
|
35 Number of AE reported
|
|
Number of Adverse Events
Post-intervention (day 11-180)
|
52 Number of AE reported
|
38 Number of AE reported
|
SECONDARY outcome
Timeframe: 90 daysRelative abundance of operational taxonomic units (OTU) classified at the phylum level
Outcome measures
| Measure |
BB-12®
n=29 Participants
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
|
Control
n=31 Participants
yogurt cultured with starter YF-L702
|
|---|---|---|
|
Overall Composition of the Gut Microbiota
Firmicutes
|
71.7 relative abundance (%)
|
74.1 relative abundance (%)
|
|
Overall Composition of the Gut Microbiota
Bacteroidetes
|
14.7 relative abundance (%)
|
11.6 relative abundance (%)
|
|
Overall Composition of the Gut Microbiota
Actinobacteria
|
11.1 relative abundance (%)
|
11.9 relative abundance (%)
|
|
Overall Composition of the Gut Microbiota
Proteobacteria
|
1.6 relative abundance (%)
|
1.4 relative abundance (%)
|
|
Overall Composition of the Gut Microbiota
Verrucomicrobia
|
0.7 relative abundance (%)
|
1.0 relative abundance (%)
|
Adverse Events
BB-12®
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BB-12®
n=29 participants at risk
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
|
Control
n=31 participants at risk
yogurt cultured with starter YF-L702
|
|---|---|---|
|
General disorders
Fever
|
3.4%
1/29 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
bronchiolitis
|
3.4%
1/29 • Number of events 1
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
3.4%
1/29 • Number of events 1
|
0.00%
0/31
|
Other adverse events
| Measure |
BB-12®
n=29 participants at risk
Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
|
Control
n=31 participants at risk
yogurt cultured with starter YF-L702
|
|---|---|---|
|
General disorders
Runny nose
|
58.6%
17/29 • Number of events 21
|
32.3%
10/31 • Number of events 12
|
|
General disorders
Other
|
17.2%
5/29
|
38.7%
12/31
|
Additional Information
Director of Research Programs
Georgetown University Medical Center, Department of Family Medicine
Phone: 202-687-1600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place