Trial Outcomes & Findings for Group B Streptococcus Response After Probiotic Exposure (NCT NCT04721912)
NCT ID: NCT04721912
Last Updated: 2025-01-14
Results Overview
Qualitative GBS colonization (positive versus negative)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
68 participants
Primary outcome timeframe
T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age)
Results posted on
2025-01-14
Participant Flow
Participant milestones
| Measure |
Standard of Care
Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.
|
Probiotic Dietary Supplement
Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.
Probiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
21
|
25
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Although 68 participants were randomized, 3 withdrew prior to obtaining age data and thus were not included in analysis.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=34 Participants
Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.
|
Probiotic Dietary Supplement
n=34 Participants
Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.
Probiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.8788 years
STANDARD_DEVIATION 5.40693 • n=33 Participants • Although 68 participants were randomized, 3 withdrew prior to obtaining age data and thus were not included in analysis.
|
29.9688 years
STANDARD_DEVIATION 6.36261 • n=32 Participants • Although 68 participants were randomized, 3 withdrew prior to obtaining age data and thus were not included in analysis.
|
29.42 years
STANDARD_DEVIATION 5.88 • n=65 Participants • Although 68 participants were randomized, 3 withdrew prior to obtaining age data and thus were not included in analysis.
|
|
Sex: Female, Male
Female
|
34 Participants
n=34 Participants
|
34 Participants
n=34 Participants
|
68 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=34 Participants
|
20 Participants
n=34 Participants
|
40 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=34 Participants
|
10 Participants
n=34 Participants
|
21 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=34 Participants
|
4 Participants
n=34 Participants
|
7 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Race · Asian
|
0 Participants
n=34 Participants
|
3 Participants
n=34 Participants
|
3 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Race · Black or African American
|
1 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Race · White
|
21 Participants
n=34 Participants
|
21 Participants
n=34 Participants
|
42 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Race · More than one race
|
2 Participants
n=34 Participants
|
1 Participants
n=34 Participants
|
3 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
10 Participants
n=34 Participants
|
9 Participants
n=34 Participants
|
19 Participants
n=68 Participants
|
|
Relationship Status
Single/widowed
|
7 Participants
n=34 Participants
|
12 Participants
n=34 Participants
|
19 Participants
n=68 Participants
|
|
Relationship Status
Partnered/married
|
24 Participants
n=34 Participants
|
18 Participants
n=34 Participants
|
42 Participants
n=68 Participants
|
|
Relationship Status
Missing
|
3 Participants
n=34 Participants
|
4 Participants
n=34 Participants
|
7 Participants
n=68 Participants
|
|
Living Arrangements
Lives with others
|
29 Participants
n=34 Participants
|
28 Participants
n=34 Participants
|
57 Participants
n=68 Participants
|
|
Living Arrangements
Lives alone
|
2 Participants
n=34 Participants
|
2 Participants
n=34 Participants
|
4 Participants
n=68 Participants
|
|
Living Arrangements
Missing
|
3 Participants
n=34 Participants
|
4 Participants
n=34 Participants
|
7 Participants
n=68 Participants
|
|
Education Level
HS/GED/some college
|
10 Participants
n=34 Participants
|
10 Participants
n=34 Participants
|
20 Participants
n=68 Participants
|
|
Education Level
College
|
12 Participants
n=34 Participants
|
13 Participants
n=34 Participants
|
25 Participants
n=68 Participants
|
|
Education Level
Graduate Degree
|
9 Participants
n=34 Participants
|
7 Participants
n=34 Participants
|
16 Participants
n=68 Participants
|
|
Education Level
Missing
|
3 Participants
n=34 Participants
|
4 Participants
n=34 Participants
|
7 Participants
n=68 Participants
|
|
Socio-economic status
<$40,000
|
7 Participants
n=34 Participants
|
7 Participants
n=34 Participants
|
14 Participants
n=68 Participants
|
|
Socio-economic status
$40,000-99,999
|
8 Participants
n=34 Participants
|
12 Participants
n=34 Participants
|
20 Participants
n=68 Participants
|
|
Socio-economic status
>$100,000
|
9 Participants
n=34 Participants
|
9 Participants
n=34 Participants
|
18 Participants
n=68 Participants
|
|
Socio-economic status
Prefer not to answer
|
7 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
7 Participants
n=68 Participants
|
|
Socio-economic status
Missing
|
3 Participants
n=34 Participants
|
6 Participants
n=34 Participants
|
9 Participants
n=68 Participants
|
|
Parity
Nulliparous
|
13 Participants
n=34 Participants
|
11 Participants
n=34 Participants
|
24 Participants
n=68 Participants
|
|
Parity
Multiparous
|
20 Participants
n=34 Participants
|
20 Participants
n=34 Participants
|
40 Participants
n=68 Participants
|
|
Parity
Missing
|
1 Participants
n=34 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age)Qualitative GBS colonization (positive versus negative)
Outcome measures
| Measure |
Standard of Care
n=21 Participants
Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.
|
Probiotic Dietary Supplement
n=25 Participants
Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.
Probiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.
|
|---|---|---|
|
GBS Culture Result (Positive Versus Negative)
Negative Qualitative GBS Colonization
|
3 Participants
|
6 Participants
|
|
GBS Culture Result (Positive Versus Negative)
Positive Qualitative GBS Colonization
|
18 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: T3 (Postpartum day 0-14, up to 8 weeks from Baseline)Population: Standard of Care participants did not receive probiotics and thus did not possess probiotic capsules to count and thus this analysis does not apply to this group.
Intervention adherence by pill count for probiotic participants
Outcome measures
| Measure |
Standard of Care
Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.
|
Probiotic Dietary Supplement
n=25 Participants
Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.
Probiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.
|
|---|---|---|
|
Probiotic Pill Count to Measure Intervention Adherence
|
—
|
14 Average Florajen Digestion Pills
Standard Deviation 7.87
|
SECONDARY outcome
Timeframe: Baseline T1 (36-37.6 weeks gestational age) and T3 (postpartum day 0-14; up to 8 weeks from baseline)Maternal gastrointestinal (GI) symptoms based on AP-GI-SA score: lowest score 10, highest score 50 (high score means more symptoms = worse outcome)
Outcome measures
| Measure |
Standard of Care
n=30 Participants
Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.
|
Probiotic Dietary Supplement
n=30 Participants
Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.
Probiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.
|
|---|---|---|
|
Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score
Baseline
|
15.6 score on a scale
Standard Deviation 3.3
|
15.0 score on a scale
Standard Deviation 3.3
|
|
Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score
Post-birth
|
14.5 score on a scale
Standard Deviation 4.8
|
13.5 score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: T1 (baseline; 36.0-37.6 weeks gestational age) through T5 (6 weeks postpartum visit; up to 12 weeks and 6 days from baseline)Maternal adverse events by organ system and severity.
Outcome measures
| Measure |
Standard of Care
n=21 Participants
Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.
|
Probiotic Dietary Supplement
n=25 Participants
Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.
Probiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.
|
|---|---|---|
|
Number of Participants Who Report Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age) through T5 (6 weeks postpartum visit; up to 12 weeks and 6 days from baseline)Infant adverse events by organ system and severity
Outcome measures
| Measure |
Standard of Care
n=21 Participants
Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.
|
Probiotic Dietary Supplement
n=25 Participants
Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.
Probiotic dietary supplement: GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.
|
|---|---|---|
|
Number of Participants Who Report Adverse Events in Their Infant
|
0 Participants
|
0 Participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Probiotic Dietary Supplement
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
Katrina Nardini, CNM, WHNP-BC, MPH
University of New Mexico
Phone: 505-205-4118
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place