Group B Strep Infection
Conditions
Keywords
pregnancy, Group B Strep positive
Brief summary
This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at term. Investigators hope to address the question of whether prenatal oral probiotic use, taken by healthy low risk GBS positive women from approximately 37 weeks gestation until the time of birth, will reduce the number of women who test positive for GBS at the time of admission to Labor and Delivery (L&D).
Detailed description
This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at term. We hope to address the question of whether prenatal oral probiotic use, taken by healthy low risk GBS positive women from approximately 37 weeks gestation until the time of birth, will reduce the number of women who test positive for GBS at the time of admission to Labor and Delivery (L&D). In this study we aim to determine whether such a study is acceptable in our population, whether any adverse events are identified, and what barriers or confounding variables might exist to probiotic use at term. We will also look at whether probiotic use had any reported effect on maternal gastrointestinal (GI) symptoms.
Interventions
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.
Sponsors
Marquette University
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Healthy pregnant participants will be randomly assigned to one of two groups (Probiotic vs No Probiotic (standard of care)). The Probiotic group will take one capsule daily and have the same study measures at the same times.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Healthy adult (≥ 18 years of age) pregnant women who are 36 - 37 6/7 weeks gestation at enrollment \[calculated from the first day of Last Normal Menstrual Period (LNMP) and/or ultrasound (US)\] Group B Streptococcus Positive at 36 weeks gestation with: * No obstetric complication requiring delivery prior to 39 weeks (hypertensive disorder diagnosed prior to enrollment, gestational diabetes, multiple gestation) * No fetal complication (e.g., birth defect, intrauterine growth restriction) * No medical complication (e.g., chronic hypertension, preexisting diabetes mellitus) * Who do not currently ingest an over the counter probiotic supplement (not including yogurt) * Who can both speak and read English or Spanish * Pregnant women who regularly attend UNM prenatal clinics for their prenatal care (regularly attend will be defined as starting prenatal care prior to 20 weeks gestation and missing no more than one prenatal appointment during this pregnancy) * No hypersensitivity reaction to β-lactam antibiotics
Exclusion criteria
* Those less than 18 years of age * Non-pregnant women * Later in pregnancy than 38 weeks gestation at enrollment \[per LNMP and/or US\] * Those with an obstetric, fetal or medical complication of pregnancy * Group B Streptococcus negative at 36 weeks gestation. Those ineligible for testing at 36 weeks gestation (history of GBS bacteriuria during the current pregnancy or have previously given birth to a GBS affected child.) We will not exclude those with bacteriuria other than GBS, and we will not exclude women who have taken an antibiotic during pregnancy, but we will track this as it is addressed in the Questionnaire for Women. * Women who are currently ingesting an over the counter probiotic supplement (except for yogurt) * Women who do not have electricity in the home. * Women who are planning an elective repeat cesarean birth * Women who do not speak and read English or Spanish * Women with a history of missing one or more scheduled prenatal visit during this pregnancy * Hypersensitivity reaction to β-lactam antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GBS Culture Result (Positive Versus Negative) | T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age) | Qualitative GBS colonization (positive versus negative) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probiotic Pill Count to Measure Intervention Adherence | T3 (Postpartum day 0-14, up to 8 weeks from Baseline) | Intervention adherence by pill count for probiotic participants |
| Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score | 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) |
| Number of Participants Who Report Adverse Events | 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. |
| Number of Participants Who Report Adverse Events in Their Infant | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| 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. | 34 |
| Total | 68 |
Baseline characteristics
| Characteristic | Probiotic Dietary Supplement | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 29.9688 years STANDARD_DEVIATION 6.36261 | 28.8788 years STANDARD_DEVIATION 5.40693 | 29.42 years STANDARD_DEVIATION 5.88 |
| Education Level College | 13 Participants | 12 Participants | 25 Participants |
| Education Level Graduate Degree | 7 Participants | 9 Participants | 16 Participants |
| Education Level HS/GED/some college | 10 Participants | 10 Participants | 20 Participants |
| Education Level Missing | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 20 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 11 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 7 Participants |
| Living Arrangements Lives alone | 2 Participants | 2 Participants | 4 Participants |
| Living Arrangements Lives with others | 28 Participants | 29 Participants | 57 Participants |
| Living Arrangements Missing | 4 Participants | 3 Participants | 7 Participants |
| Parity Missing | 3 Participants | 1 Participants | 4 Participants |
| Parity Multiparous | 20 Participants | 20 Participants | 40 Participants |
| Parity Nulliparous | 11 Participants | 13 Participants | 24 Participants |
| Race (NIH/OMB) Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Race Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Race More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 9 Participants | 10 Participants | 19 Participants |
| Race (NIH/OMB) Race White | 21 Participants | 21 Participants | 42 Participants |
| Relationship Status Missing | 4 Participants | 3 Participants | 7 Participants |
| Relationship Status Partnered/married | 18 Participants | 24 Participants | 42 Participants |
| Relationship Status Single/widowed | 12 Participants | 7 Participants | 19 Participants |
| Sex: Female, Male Female | 34 Participants | 34 Participants | 68 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Socio-economic status >$100,000 | 9 Participants | 9 Participants | 18 Participants |
| Socio-economic status <$40,000 | 7 Participants | 7 Participants | 14 Participants |
| Socio-economic status $40,000-99,999 | 12 Participants | 8 Participants | 20 Participants |
| Socio-economic status Missing | 6 Participants | 3 Participants | 9 Participants |
| Socio-economic status Prefer not to answer | 0 Participants | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
GBS Culture Result (Positive Versus Negative)
Qualitative GBS colonization (positive versus negative)
Time frame: T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | GBS Culture Result (Positive Versus Negative) | Positive Qualitative GBS Colonization | 18 Participants |
| Standard of Care | GBS Culture Result (Positive Versus Negative) | Negative Qualitative GBS Colonization | 3 Participants |
| Probiotic Dietary Supplement | GBS Culture Result (Positive Versus Negative) | Negative Qualitative GBS Colonization | 6 Participants |
| Probiotic Dietary Supplement | GBS Culture Result (Positive Versus Negative) | Positive Qualitative GBS Colonization | 19 Participants |
Secondary
Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score
Maternal gastrointestinal (GI) symptoms based on AP-GI-SA score: lowest score 10, highest score 50 (high score means more symptoms = worse outcome)
Time frame: Baseline T1 (36-37.6 weeks gestational age) and T3 (postpartum day 0-14; up to 8 weeks from baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score | Baseline | 15.6 score on a scale | Standard Deviation 3.3 |
| Standard of Care | Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score | Post-birth | 14.5 score on a scale | Standard Deviation 4.8 |
| Probiotic Dietary Supplement | Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score | Baseline | 15.0 score on a scale | Standard Deviation 3.3 |
| Probiotic Dietary Supplement | Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score | Post-birth | 13.5 score on a scale | Standard Deviation 4.7 |
Secondary
Number of Participants Who Report Adverse Events
Maternal adverse events by organ system and severity.
Time frame: T1 (baseline; 36.0-37.6 weeks gestational age) through T5 (6 weeks postpartum visit; up to 12 weeks and 6 days from baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants Who Report Adverse Events | 0 Participants |
| Probiotic Dietary Supplement | Number of Participants Who Report Adverse Events | 0 Participants |
Secondary
Number of Participants Who Report Adverse Events in Their Infant
Infant adverse events by organ system and severity
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants Who Report Adverse Events in Their Infant | 0 Participants |
| Probiotic Dietary Supplement | Number of Participants Who Report Adverse Events in Their Infant | 0 Participants |
Secondary
Probiotic Pill Count to Measure Intervention Adherence
Intervention adherence by pill count for probiotic participants
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Probiotic Dietary Supplement | Probiotic Pill Count to Measure Intervention Adherence | 14 Average Florajen Digestion Pills | Standard Deviation 7.87 |