Trial Outcomes & Findings for Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy (NCT NCT01479478)
NCT ID: NCT01479478
Last Updated: 2018-08-20
Results Overview
Gestational age is given in a format of full weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
251 participants
Primary outcome timeframe
35 to 37 weeks gestational age
Results posted on
2018-08-20
Participant Flow
Only expecting mothers were enrolled in this study. Neonatal data were collected from respective pregnancies, however, the neonates were not considered to be enrolled in this study.
Participant milestones
| Measure |
Probiotic Dietary Supplement
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
126
|
|
Overall Study
COMPLETED
|
125
|
126
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy
Baseline characteristics by cohort
| Measure |
Probiotic Dietary Supplement
n=125 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=126 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
31.9 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
31.7 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic white
|
66 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic other
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
125 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Pre-pregnancy Body Mass Index
|
26.1 kg/m^2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
26.0 kg/m^2
STANDARD_DEVIATION 7.5 • n=7 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 35 to 37 weeks gestational agePopulation: Participants with available data were included in the analysis
Gestational age is given in a format of full weeks.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=108 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=117 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age
|
20 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: From enrollment up to delivery hospitalization (up to 42 weeks gestation)Population: Participants with available data were included in the analysis.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=118 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=123 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Participants With Urinary Tract Infection
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From time of labor onset until delivery (up to 42 weeks of gestation)Population: Participants with available data were included in the analysis.
Intrapartum chorioamnionitis is maternal temperature above 38.0 degrees Celsius and one or more of the following findings: fetal tachycardia; maternal tachycardia; uterine tenderness; purulent or malodorous amniotic fluid, or elevated maternal white blood cell count.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=118 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=121 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Participants With Intrapartum Chorioamnionitis
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From time of delivery up to 6 weeks postpartumPopulation: Participants with available data were included in the analysis.
Endometritis is a uterine (myometrial) infection.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=116 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=119 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Participants With Endometritis
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From time of delivery up to 6 weeks postpartumPopulation: Participants with available data were included in the analysis.
Cellulitis is a bacterial skin infection.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=118 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=123 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Participants With Cellulitis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of labor onset up to 6 weeks postpartumPopulation: Participants with available data were included in the analysis.
Bacteremia is defined as presence of bacteria in the blood.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=116 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=119 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Participants With Bacteremia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From labor onset up to 6 weeks postpartumPopulation: Participants with available data were included in the analysis.
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated response of the body to an infection.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=116 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=119 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Participants With Sepsis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of labor onset up to 6 weeks postpartumPopulation: Participants with available data were included in the analysis.
Other infectious morbidity included maternal mastitis or pneumonia.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=116 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=119 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Participants With Other Infectious Morbidity
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At time of delivery (up to 42 weeks of gestation)Population: Participants with available data were included in the analysis.
Gestational age at delivery is presented as weeks.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=117 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=121 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Gestational Age at Delivery
|
39.6 weeks
Interval 39.0 to 40.6
|
39.4 weeks
Interval 38.7 to 40.3
|
SECONDARY outcome
Timeframe: At time of delivery (up to 42 weeks of gestation)Population: Participants with available data were included in the analysis.
Apgar score is a measure to quickly assess the neonatal health status from time of delivery. Score ranges from 0-10. Lower scores correspond to worse health state; neonates with scores below 5 are considered to have poor prognosis.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=113 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=119 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Apgar Score at 1 and 5 Minutes Following Delivery
At 1 minute
|
8 units on a scale
Interval 7.0 to 9.0
|
8 units on a scale
Interval 8.0 to 9.0
|
|
Apgar Score at 1 and 5 Minutes Following Delivery
At 5 minutes
|
9 units on a scale
Interval 9.0 to 9.0
|
9 units on a scale
Interval 9.0 to 9.0
|
SECONDARY outcome
Timeframe: Up to 14 days following deliveryPopulation: Participants with available data were included in the analysis.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=104 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=94 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Neonatal Bilirubin Level
|
6.4 mg/dL
Interval 5.1 to 9.6
|
6.5 mg/dL
Interval 4.9 to 9.4
|
SECONDARY outcome
Timeframe: Up to 14 days following deliveryPopulation: Participants with available data were included in the analysis.
Maximum neonatal C-reactive protein level
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=23 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=18 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Neonatal C-reactive Protein Level
|
1.6 mg/L
Interval 0.3 to 4.1
|
1.2 mg/L
Interval 0.4 to 2.9
|
SECONDARY outcome
Timeframe: Up to 14 days following deliveryPopulation: Participants with available data were included in the analysis.
Outcome was based on performance of neonatal blood culture.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=115 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=121 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Neonates Requiring a "Rule-out Sepsis Evaluation"
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 14 days following deliveryPopulation: Participants with available data were included in the analysis.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=115 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=121 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Neonates With Sepsis
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 14 days following deliveryPopulation: Participants with available data were included in the analysis.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=115 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=121 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Neonates With Pneumonia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 14 days following deliveryPopulation: Participants with available data were included in the analysis.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=115 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=121 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Neonates With Meningitis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 14 days following deliveryPopulation: Participants with available data were included in the analysis.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=115 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=121 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Count of Neonates With Intensive-care Unit Admission
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 14 days following deliveryPopulation: Participants with available data were included in the analysis.
Outcome measures
| Measure |
Probiotic Dietary Supplement
n=113 Participants
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=116 Participants
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Length of Neonatal Hospital Stay
|
2 days
Interval 2.0 to 3.0
|
2 days
Interval 2.0 to 2.5
|
Adverse Events
Probiotic Dietary Supplement
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Probiotic Dietary Supplement
n=125 participants at risk
Probiotic dietary supplement one capsule once per day until delivery.
Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
|
Placebo
n=126 participants at risk
Placebo capsule, one daily until delivery.
Placebo: One placebo capsule daily.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Any other anticipated or unanticipated life-threatening event:intra-uterine fetal growth restriction
|
0.80%
1/125 • From enrollment up to 6 weeks following delivery.
|
0.00%
0/126 • From enrollment up to 6 weeks following delivery.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place