Group B Strep InfectionPhase 3GRAPENCT04721912
Group B Streptococcus Response After Probiotic Exposure
A Phase 3 study testing Probiotic dietary supplement in people with Group B Strep Infection, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Group B Strep Infection
- What is being tested?
- Probiotic dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Dec 2020to 31 Aug 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Hospital
Albuquerque, New Mexico, 87112
About this study
Official title: Open-label Randomized Control Trial and Feasibility Study of Florjajen Digestion Probiotics to Reduce GBS Colonization in Pregnant Women by the Time of Birth.
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).
Read the 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.
- Conditions
- Group B Strep Infection
- Being tested
- Probiotic dietary supplement
- Keywords
- pregnancy, Group B Strep positive
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic dietary supplementDrug
Also called Florajen Digestion™
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | 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 | Experimental | 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. Receives: Drug: Probiotic dietary supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
GBS Culture Result (Positive Versus Negative)
Qualitative GBS colonization (positive versus negative)
Measured: T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age)
Secondary outcomes (4)
Probiotic Pill Count to Measure Intervention Adherence
Intervention adherence by pill count for probiotic participants
Measured: T3 (Postpartum day 0-14, up to 8 weeks from Baseline)
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)
Measured: Baseline T1 (36-37.6 weeks gestational age) and T3 (postpartum day 0-14; up to 8 weeks from baseline)
Number of Participants Who Report Adverse Events
Maternal adverse events by organ system and severity.
Measured: T1 (baseline; 36.0-37.6 weeks gestational age) through T5 (6 weeks postpartum visit; up to 12 weeks and 6 days from baseline)
Number of Participants Who Report Adverse Events in Their Infant
Infant adverse events by organ system and severity
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start24 Dec 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Group B Strep InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Marquette University
- Responsible party
- Principal investigator, Katrina A. Nardini, University of New Mexico
- Investigators
- Katrina Nardini, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721912
- Sponsor's protocol ID
- 20-396
- Acronym
- GRAPE
- Status last verified
- Jan 2025
- First submitted
- 7 Dec 2020
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nardini K, Hanson L, Borders N, Singh M, Shields A, Trujillo VY, Lawton R, Malloy E. Open-Label Randomized Controlled Trial and Feasibility Study of an Oral Probiotic Intervention to Reduce Group B Streptococcus Colonization in Pregnant People by the Time of Birth. J Midwifery Womens Health. 2025 May-Jun;70(3):460-467. doi: 10.1111/jmwh.13765. Epub 2025 May 29.
PubMed 40442923
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Randomized Control Trial and Feasibility Study of Florjajen Digestion Probiotics to Reduce GBS Colonization in Pregnant Women by the Time of Birth.
- ClinicalTrials.gov ID
- NCT04721912
- Acronym / sponsor ID
- GRAPE / 20-396
- Conditions
- Group B Strep Infection
- Keywords
- pregnancy, Group B Strep positive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Marquette University
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –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 | Experimental | Drug: Probiotic dietary supplementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)]
- 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)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic dietary supplementAlso: Florajen Digestion™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. | Drug | Probiotic Dietary Supplement |
Primary outcome
GBS Culture Result (Positive Versus Negative)
Time frame: T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age)
Qualitative GBS colonization (positive versus negative)
4 secondary outcomes
Probiotic Pill Count to Measure Intervention Adherence
Time frame: T3 (Postpartum day 0-14, up to 8 weeks from Baseline)
Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score
Time frame: Baseline T1 (36-37.6 weeks gestational age) and T3 (postpartum day 0-14; up to 8 weeks from baseline)
Number of Participants Who Report Adverse Events
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)
Number of Participants Who Report Adverse Events in Their Infant
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40442923Nardini K, Hanson L, Borders N, Singh M, Shields A, Trujillo VY, Lawton R, Malloy E. Open-Label Randomized Controlled Trial and Feasibility Study of an Oral Probiotic Intervention to Reduce Group B Streptococcus Colonization in Pregnant People by the Time of Birth. J Midwifery Womens Health. 2025 May-Jun;70(3):460-467. doi: 10.1111/jmwh.13765. Epub 2025 May 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrina Nardini principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic dietary supplement in people with Group B Strep Infection, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GBS Culture Result (Positive Versus Negative) (time frame: T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04721912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.