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Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy

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ClinicalTrials.gov Identifier: NCT01479478
Recruitment Status : Completed
First Posted : November 24, 2011
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Natali Aziz, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Infection
Pregnancy
Interventions Drug: Placebo
Dietary Supplement: Probiotic dietary supplement
Enrollment 251

Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Period Title: Overall Study
Started 125 126
Completed 125 126
Not Completed 0 0
Arm/Group Title Probiotic Dietary Supplement Placebo Total
Hide Arm/Group Description

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Total of all reporting groups
Overall Number of Baseline Participants 125 126 251
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants 126 participants 251 participants
31.4  (5.7) 31.9  (5.3) 31.7  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
Female
125
 100.0%
126
 100.0%
251
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
Non-Hispanic white
66
  52.8%
71
  56.3%
137
  54.6%
Non-Hispanic other
21
  16.8%
22
  17.5%
43
  17.1%
Hispanic
32
  25.6%
26
  20.6%
58
  23.1%
Unknown
6
   4.8%
7
   5.6%
13
   5.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 125 participants 126 participants 251 participants
125
 100.0%
126
 100.0%
251
 100.0%
Pre-pregnancy Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 125 participants 126 participants 251 participants
26.1  (6.5) 26.0  (7.5) 26.1  (7)
1.Primary Outcome
Title Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age
Hide Description Gestational age is given in a format of full weeks.
Time Frame 35 to 37 weeks gestational age
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 108 117
Measure Type: Count of Participants
Unit of Measure: Participants
20
  18.5%
23
  19.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Probiotic Dietary Supplement, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Count of Participants With Urinary Tract Infection
Hide Description [Not Specified]
Time Frame From enrollment up to delivery hospitalization (up to 42 weeks gestation)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 118 123
Measure Type: Count of Participants
Unit of Measure: Participants
8
   6.8%
9
   7.3%
3.Secondary Outcome
Title Count of Participants With Intrapartum Chorioamnionitis
Hide Description 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.
Time Frame From time of labor onset until delivery (up to 42 weeks of gestation)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 118 121
Measure Type: Count of Participants
Unit of Measure: Participants
5
   4.2%
4
   3.3%
4.Secondary Outcome
Title Count of Participants With Endometritis
Hide Description Endometritis is a uterine (myometrial) infection.
Time Frame From time of delivery up to 6 weeks postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 116 119
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
   1.7%
5.Secondary Outcome
Title Count of Participants With Cellulitis
Hide Description Cellulitis is a bacterial skin infection.
Time Frame From time of delivery up to 6 weeks postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 118 123
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Count of Participants With Bacteremia
Hide Description Bacteremia is defined as presence of bacteria in the blood.
Time Frame From time of labor onset up to 6 weeks postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 116 119
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Count of Participants With Sepsis
Hide Description Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated response of the body to an infection.
Time Frame From labor onset up to 6 weeks postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 116 119
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Count of Participants With Other Infectious Morbidity
Hide Description Other infectious morbidity included maternal mastitis or pneumonia.
Time Frame From time of labor onset up to 6 weeks postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 116 119
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Gestational Age at Delivery
Hide Description Gestational age at delivery is presented as weeks.
Time Frame At time of delivery (up to 42 weeks of gestation)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 117 121
Median (Inter-Quartile Range)
Unit of Measure: weeks
39.6
(39.0 to 40.6)
39.4
(38.7 to 40.3)
10.Secondary Outcome
Title Apgar Score at 1 and 5 Minutes Following Delivery
Hide Description 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.
Time Frame At time of delivery (up to 42 weeks of gestation)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 113 119
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
At 1 minute
8
(7 to 9)
8
(8 to 9)
At 5 minutes
9
(9 to 9)
9
(9 to 9)
11.Secondary Outcome
Title Neonatal Bilirubin Level
Hide Description [Not Specified]
Time Frame Up to 14 days following delivery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 104 94
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
6.4
(5.1 to 9.6)
6.5
(4.9 to 9.4)
12.Secondary Outcome
Title Neonatal C-reactive Protein Level
Hide Description Maximum neonatal C-reactive protein level
Time Frame Up to 14 days following delivery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 23 18
Median (Inter-Quartile Range)
Unit of Measure: mg/L
1.6
(0.3 to 4.1)
1.2
(0.4 to 2.9)
13.Secondary Outcome
Title Count of Neonates Requiring a "Rule-out Sepsis Evaluation"
Hide Description Outcome was based on performance of neonatal blood culture.
Time Frame Up to 14 days following delivery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 115 121
Measure Type: Count of Participants
Unit of Measure: Participants
9
   7.8%
4
   3.3%
14.Secondary Outcome
Title Count of Neonates With Sepsis
Hide Description [Not Specified]
Time Frame Up to 14 days following delivery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 115 121
Measure Type: Count of Participants
Unit of Measure: Participants
4
   3.5%
1
   0.8%
15.Secondary Outcome
Title Count of Neonates With Pneumonia
Hide Description [Not Specified]
Time Frame Up to 14 days following delivery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 115 121
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Count of Neonates With Meningitis
Hide Description [Not Specified]
Time Frame Up to 14 days following delivery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 115 121
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Count of Neonates With Intensive-care Unit Admission
Hide Description [Not Specified]
Time Frame Up to 14 days following delivery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 115 121
Measure Type: Count of Participants
Unit of Measure: Participants
12
  10.4%
7
   5.8%
18.Secondary Outcome
Title Length of Neonatal Hospital Stay
Hide Description [Not Specified]
Time Frame Up to 14 days following delivery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description:

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

Overall Number of Participants Analyzed 113 116
Median (Inter-Quartile Range)
Unit of Measure: days
2
(2 to 3)
2
(2 to 2.5)
Time Frame From enrollment up to 6 weeks following delivery.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Probiotic Dietary Supplement Placebo
Hide Arm/Group Description

Probiotic dietary supplement one capsule once per day until delivery.

Probiotic dietary supplement: Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Placebo capsule, one daily until delivery.

Placebo: One placebo capsule daily.

All-Cause Mortality
Probiotic Dietary Supplement Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/125 (0.00%)   0/126 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Probiotic Dietary Supplement Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/125 (0.80%)   0/126 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Any other anticipated or unanticipated life-threatening event:intra-uterine fetal growth restriction   1/125 (0.80%)  0/126 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Probiotic Dietary Supplement Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/125 (0.00%)   0/126 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Natali Aziz, MD
Organization: Stanford University
Phone: 650-725-5720
Responsible Party: Natali Aziz, Stanford University
ClinicalTrials.gov Identifier: NCT01479478     History of Changes
Other Study ID Numbers: 18840
First Submitted: November 22, 2011
First Posted: November 24, 2011
Results First Submitted: July 18, 2018
Results First Posted: August 20, 2018
Last Update Posted: August 20, 2018