Group B Streptococcus Carrier in ChildbirthPhase 2NCT03696953
The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization.
A Phase 2 study testing Florajen3 in people with Group B Streptococcus Carrier in Childbirth and Gastrointestinal Symptoms, run by Marquette University at 1 site in United States.
Trial summary
This study is a randomized double blind, placebo controlled trial to determine the efficacy of an oral probiotic in reducing antenatal Group B Streptococcus colonization. The goal of this study is to demonstrate that women in the probiotics group will experience; (1) reduced GBS prenatal colonization at 36± 2 weeks… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Group B Streptococcus Carrier in Childbirth, Gastrointestinal Symptoms
- What is being tested?
- Florajen3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 30 Sep 2024
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult (≥ 18 years of age) pregnant women who are 28±2 weeks gestation at enrollment [calculated from the first day of Last Normal Menstrual Period (LNMP) and/or ultrasound (US)]
- With: No obstetric complication* (e.g., pre-eclampsia, gestational diabetes, multiple gestation)
- No fetal complication (e.g., birth defect, intrauterine growth restriction)
- No medical complication (e.g., hypertension, diabetes mellitus)
- Who do not currently ingest an over the counter probiotic supplement (not including yogurt)
- Who can both speak and read English
- Who regularly attend prenatal care (defined as not > 1 prior missed 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 30 weeks gestation at enrollment [per LNMP and/or US]
- Those with an obstetric, fetal or medical complication of pregnancy
- Pregnant women who have a history of GBS bacteriuria during the current pregnancy or have previously given birth to a GBS affected child
- Women who are currently ingesting an over the counter probiotic supplement (except for yogurt)
Show all 10Show fewer
- Women who are planning an elective repeat cesarean birth
- Women who do not speak and read English
- Women with a history of missing more than one scheduled prenatal visit during this pregnancy
- Hypersensitivity reaction to β-lactam antibiotics
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
About this study
Official title: The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization
This study is a randomized double blind, placebo controlled trial to determine the efficacy of an oral probiotic in reducing antenatal Group B Streptococcus colonization. The goal of this study is to demonstrate that women in the probiotics group will experience; (1) reduced GBS prenatal colonization at 36± 2 weeks gestation and lower levels of GBS colonization, (2) less need for intrapartum antibiotic prophylaxis and (3) fewer prenatal gastrointestinal symptoms compared to women in the placebo group.
Intrapartum measures were added and IRB approved in Feb 2020 as a pilot and feasibility substudy. The goals of this study are as follows: (1) Explore the effect of antepartum exposure to Florajen3 on maternal and neonatal residual GBS and the maternal microbiome. We anticipate that (1)At the time of labor, more women in the probiotics group will test negative for GBS on vaginal to rectal swabs compared to those in the placebo group and (2) Fewer neonates born to women in the probiotic group will have GBS on nasal-oral pharynx cultures within several hours of birth compared to those born to neonates in the control group.
Read the detailed description
Group B streptococcus (GBS) is the most prevalent cause of perinatal infection, with mortality and profound comorbidities for neonates. Vaginal and gastrointestinal (GI) colonization with GBS occurs in up to 30% of adult women, with highest rates in African Americans. Pregnant women can pass GBS to their fetuses during vaginal birth, putting them at risk for Early Onset Group B Streptococcus Disease (EOGBSD), which is associated with a neonatal mortality rate of 5-10% and morbidity of approximately 50%. The Centers for Disease Control and Prevention (CDC) 2010 guidelines require universal antepartum GBS screening by vaginal to rectal cultures of all women at 35-37 weeks gestation, and intravenously administered intrapartum antibiotic prophylaxis (IAP) of two or more doses if a woman is found to be colonized with GBS. While use of these guidelines has significantly reduced EOGBSD incidence from 1.7 per 1,000 live births to 0.34-0.37, up to 30% of laboring women and their fetuses are exposed to IAP. Complications associated with IAP are significant for both the mother (increased incidence of antibiotic resistance, allergic sensitization, diarrhea including Clostridium difficile, and fungal infections) and neonate (gut dysbiosis, opportunistic infections, and allergic risk). The proposed study will test a low-cost, safe, innovative approach to reduce prenatal colonization with GBS, while adhering to CDC guidelines for EOGBSD prevention. Investigators hypothesize that women who ingest a commercially available oral probiotic combination product (Florajen3, containing Lactobacillus acidophilus, Bifidobacterium lactis, and Bifidobacterium longum) daily from 28 weeks gestation through the time of labor will have a lower risk of GBS colonization compared to women taking placebo. The purpose of this Phase 2 placebo-controlled, double blind, randomized controlled trial (RCT) is to determine the efficacy of once daily ingestion of Florajen3 by healthy low-risk pregnant women from 28 weeks gestation until the time of labor to (a) reduce the proportion of women with GBS colonization and thus (b) reduce the number of women who receive IAP. Investigators expect this intervention to alter the vaginal and rectal microbiota by (c) increasing Lactobacillus colony counts, (d) decreasing GBS colony counts, and (e) reducing GI symptoms. In preparation for this RCT, the research team conducted two preliminary studies (one in vitro, one in vivo), an integrative review of the literature regarding the use of prenatal probiotics, and a systematic review on probiotics and urogynecologic infections. The literature and preliminary work support the safety, tolerability, and potentially high impact of the oral probiotic as an innovative, low-risk, easy-to-use intervention to reduce GBS colonization during pregnancy and significantly reduce exposure of mothers and infants to IAP and the associated complications. If positive, findings from this study will shift the paradigm in clinical practice and be used to design and conduct a larger RCT to extend the science of nursing, midwifery, obstetrics, microbiology, clinical nutrition, and infectious disease for care of pregnant women and their infants.
Approximately 10% of women who tested negative for GBS at 36 weeks will become positive at the time of labor and birth. This "residual GBS" may be responsible for cases of EOGBSD cases.
- Being tested
- Florajen3
- Keywords
- Probiotics, Pregnancy, Group B Streptococcus, Gastrointestinal symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Florajen3Biological
Probiotic combination product One capsule daily by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Florajen3 Combination Probiotic Product 15 billion CFU per capsule
1 capsule daily from 28 weeks until the time of birth. Receives: Biological: Florajen3 |
| Placebo | No intervention | Microcrystalline Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative GBS Culture Result
Qualitative GBS culture results
Measured: 36 weeks gestation
Secondary outcomes (2)
GBS Quantitative Colony Counts in Colony Forming Units (CFU)
Amount of GBS on each vaginal and rectal swab. Each swab was vortexed in 1 mL of PBS and plated onto Granada agar. Quantitative GBS colonization measured as the number of GBS colonies on Granada agar plate multiplied by the inverse of the dilution factor. The results were reported in CFU. No GBS present indicates negative. Positive results are reports numerically.
Measured: 36 weeks gestation
Antepartum Gastrointestinal Symptom Assessment
Antepartum Gastrointestinal Symptom Assessment Scores
The Antepartum Gastrointestinal Symptom Assessment is a composite of 10 GI symptoms (Nausea, Vomiting, Diarrhea, Sour Taste, Bad Breath, Burping/Belching, Bloating, Heartburn, Diarrhea, Constipation) each scored from 1 (no problem) to 5 (very severe problem), leading to a composite score between 10-50. Lower scores indicate fewer and/or less severe GI symptoms. Higher scores indicate more frequent and/or more severe GI symptoms.
Measured: 36 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start1 Feb 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2024 (estimated)
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 (9)Papers the sponsor has linked to this study.
- Other trials for Group B Streptococcus Carrier in ChildbirthStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Healthy pregnant participants will be randomly assigned to one of two groups (Probiotic vs Placebo) that are blind to participants and researchers. Both groups will take one capsule daily and have the same study measures at the same times.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa C Hanson, PhD, Principal investigator, Marquette University, College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696953
- Sponsor's protocol ID
- R21HD095320
- Status last verified
- Mar 2024
- First submitted
- 1 Oct 2018
- Last updated
- 21 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanson L, Vandevusse L, Duster M, Warrack S, Safdar N. Feasibility of oral prenatal probiotics against maternal group B Streptococcus vaginal and rectal colonization. J Obstet Gynecol Neonatal Nurs. 2014 May-Jun;43(3):294-304. doi: 10.1111/1552-6909.12308. Epub 2014 Apr 22.
PubMed 24754328Hanson L, VandeVusse L, Jerme M, Abad CL, Safdar N. Probiotics for Treatment and Prevention of Urogenital Infections in Women: A Systematic Review. J Midwifery Womens Health. 2016 May;61(3):339-55. doi: 10.1111/jmwh.12472.
PubMed 27218592VandeVusse L, Hanson L, Safdar N. Perinatal outcomes of prenatal probiotic and prebiotic administration: an integrative review. J Perinat Neonatal Nurs. 2013 Oct-Dec;27(4):288-301; quiz E1-2. doi: 10.1097/JPN.0b013e3182a1e15d.
PubMed 24164813Hanson L, Vandevusse L. Probiotics are food; herbs are plants; what's the risk? Informed consent for complementary and integrative therapies. J Perinat Neonatal Nurs. 2010 Jul-Sep;24(3):201-4. doi: 10.1097/JPN.0b013e3181e8f930. No abstract available.
PubMed 20697235Dunn AB, Hanson L, VandeVusse L, Leslie S. Through the Microbial Looking Glass: Premature Labor, Preeclampsia, and Gestational Diabetes: A Scoping Review. J Perinat Neonatal Nurs. 2019 Jan/Mar;33(1):35-51. doi: 10.1097/JPN.0000000000000375.
PubMed 30676461Simonson J, Haglund K, Weber E, Fial A, Hanson L. Probiotics for the Management of Infantile Colic: A Systematic Review. MCN Am J Matern Child Nurs. 2021 Mar-Apr 01;46(2):88-96. doi: 10.1097/NMC.0000000000000691.
PubMed 33315632Malloy E, Kates A, Watson L, VandeVusse L, Safdar N, Hanson L. Laboratory Analysis Techniques for the Perinatal Microbiome: Implications for Studies of Probiotic Interventions. J Perinat Neonatal Nurs. 2020 Jul/Sep;34(3):239-250. doi: 10.1097/JPN.0000000000000496.
PubMed 32697544Hanson L, VandeVusse L, Forgie M, Malloy E, Singh M, Scherer M, Kleber D, Dixon J, Hryckowian AJ, Safdar N. A randomized controlled trial of an oral probiotic to reduce antepartum group B Streptococcus colonization and gastrointestinal symptoms. Am J Obstet Gynecol MFM. 2023 Jan;5(1):100748. doi: 10.1016/j.ajogmf.2022.100748. Epub 2022 Sep 13.
PubMed 36108911Hanson L, Albert K, Malloy E, Singh M, Kallay M, Brandt A, Morris C, Kleber D, Forgie M. Participant Personal Characteristics and Adherence to Oral Capsules: A Secondary Analysis of a Randomized Placebo-Controlled Trial of Antenatal Probiotics. J Midwifery Womens Health. 2025 May-Jun;70(3):452-459. doi: 10.1111/jmwh.13686. Epub 2024 Oct 1.
PubMed 39351987
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization
- ClinicalTrials.gov ID
- NCT03696953
- Acronym / sponsor ID
- R21HD095320
- Keywords
- Probiotics, Pregnancy, Group B Streptococcus, Gastrointestinal symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, University of Wisconsin, Madison
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 5 Oct 2018 (actual)
- Results
- Posted 21 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized double blind, placebo controlled trial to determine the efficacy of an oral probiotic in reducing antenatal Group B Streptococcus colonization. The goal of this study is to demonstrate that women in the probiotics group will experience; (1) reduced GBS prenatal colonization at 36± 2 weeks gestation and lower levels of GBS colonization, (2) less need for intrapartum antibiotic prophylaxis and (3) fewer prenatal gastrointestinal symptoms compared to women in the placebo group.
Intrapartum measures were added and IRB approved in Feb 2020 as a pilot and feasibility substudy. The goals of this study are as follows: (1) Explore the effect of antepartum exposure to Florajen3 on maternal and neonatal residual GBS and the maternal microbiome. We anticipate that (1)At the time of labor, more women in the probiotics group will test negative for GBS on vaginal to rectal swabs compared to those in the placebo group and (2) Fewer neonates born to women in the probiotic group will have GBS on nasal-oral pharynx cultures within several hours of birth compared to those born to neonates in the control group.
Detailed description
Group B streptococcus (GBS) is the most prevalent cause of perinatal infection, with mortality and profound comorbidities for neonates. Vaginal and gastrointestinal (GI) colonization with GBS occurs in up to 30% of adult women, with highest rates in African Americans. Pregnant women can pass GBS to their fetuses during vaginal birth, putting them at risk for Early Onset Group B Streptococcus Disease (EOGBSD), which is associated with a neonatal mortality rate of 5-10% and morbidity of approximately 50%. The Centers for Disease Control and Prevention (CDC) 2010 guidelines require universal antepartum GBS screening by vaginal to rectal cultures of all women at 35-37 weeks gestation, and intravenously administered intrapartum antibiotic prophylaxis (IAP) of two or more doses if a woman is found to be colonized with GBS. While use of these guidelines has significantly reduced EOGBSD incidence from 1.7 per 1,000 live births to 0.34-0.37, up to 30% of laboring women and their fetuses are exposed to IAP. Complications associated with IAP are significant for both the mother (increased incidence of antibiotic resistance, allergic sensitization, diarrhea including Clostridium difficile, and fungal infections) and neonate (gut dysbiosis, opportunistic infections, and allergic risk). The proposed study will test a low-cost, safe, innovative approach to reduce prenatal colonization with GBS, while adhering to CDC guidelines for EOGBSD prevention. Investigators hypothesize that women who ingest a commercially available oral probiotic combination product (Florajen3, containing Lactobacillus acidophilus, Bifidobacterium lactis, and Bifidobacterium longum) daily from 28 weeks gestation through the time of labor will have a lower risk of GBS colonization compared to women taking placebo. The purpose of this Phase 2 placebo-controlled, double blind, randomized controlled trial (RCT) is to determine the efficacy of once daily ingestion of Florajen3 by healthy low-risk pregnant women from 28 weeks gestation until the time of labor to (a) reduce the proportion of women with GBS colonization and thus (b) reduce the number of women who receive IAP. Investigators expect this intervention to alter the vaginal and rectal microbiota by (c) increasing Lactobacillus colony counts, (d) decreasing GBS colony counts, and (e) reducing GI symptoms. In preparation for this RCT, the research team conducted two preliminary studies (one in vitro, one in vivo), an integrative review of the literature regarding the use of prenatal probiotics, and a systematic review on probiotics and urogynecologic infections. The literature and preliminary work support the safety, tolerability, and potentially high impact of the oral probiotic as an innovative, low-risk, easy-to-use intervention to reduce GBS colonization during pregnancy and significantly reduce exposure of mothers and infants to IAP and the associated complications. If positive, findings from this study will shift the paradigm in clinical practice and be used to design and conduct a larger RCT to extend the science of nursing, midwifery, obstetrics, microbiology, clinical nutrition, and infectious disease for care of pregnant women and their infants.
Approximately 10% of women who tested negative for GBS at 36 weeks will become positive at the time of labor and birth. This "residual GBS" may be responsible for cases of EOGBSD cases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Healthy pregnant participants will be randomly assigned to one of two groups (Probiotic vs Placebo) that are blind to participants and researchers. Both groups will take one capsule daily and have the same study measures at the same times.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Biological: Florajen3Florajen3 Combination Probiotic Product 15 billion CFU per capsule 1 capsule daily from 28 weeks until the time of birth. |
| Placebo | No intervention | –Microcrystalline Cellulose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy adult (≥ 18 years of age) pregnant women who are 28±2 weeks gestation at enrollment [calculated from the first day of Last Normal Menstrual Period (LNMP) and/or ultrasound (US)]
- With: No obstetric complication* (e.g., pre-eclampsia, gestational diabetes, multiple gestation)
- No fetal complication (e.g., birth defect, intrauterine growth restriction)
- No medical complication (e.g., hypertension, diabetes mellitus)
- Who do not currently ingest an over the counter probiotic supplement (not including yogurt)
Key exclusion criteria (10 listed)
- Those less than 18 years of age
- Non-pregnant women
- Later in pregnancy than 30 weeks gestation at enrollment [per LNMP and/or US]
- Those with an obstetric, fetal or medical complication of pregnancy
- Pregnant women who have a history of GBS bacteriuria during the current pregnancy or have previously given birth to a GBS affected child
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 |
|---|---|---|
| Florajen3Probiotic combination product One capsule daily by mouth. | Biological | Probiotic |
Primary outcome
Qualitative GBS Culture Result
Time frame: 36 weeks gestation
Qualitative GBS culture results
2 secondary outcomes
GBS Quantitative Colony Counts in Colony Forming Units (CFU)
Time frame: 36 weeks gestation
Antepartum Gastrointestinal Symptom Assessment
Time frame: 36 weeks gestation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24754328Hanson L, Vandevusse L, Duster M, Warrack S, Safdar N. Feasibility of oral prenatal probiotics against maternal group B Streptococcus vaginal and rectal colonization. J Obstet Gynecol Neonatal Nurs. 2014 May-Jun;43(3):294-304. doi: 10.1111/1552-6909.12308. Epub 2014 Apr 22.
- Background: PubMed 27218592Hanson L, VandeVusse L, Jerme M, Abad CL, Safdar N. Probiotics for Treatment and Prevention of Urogenital Infections in Women: A Systematic Review. J Midwifery Womens Health. 2016 May;61(3):339-55. doi: 10.1111/jmwh.12472.
- Background: PubMed 24164813VandeVusse L, Hanson L, Safdar N. Perinatal outcomes of prenatal probiotic and prebiotic administration: an integrative review. J Perinat Neonatal Nurs. 2013 Oct-Dec;27(4):288-301; quiz E1-2. doi: 10.1097/JPN.0b013e3182a1e15d.
- Background: PubMed 20697235Hanson L, Vandevusse L. Probiotics are food; herbs are plants; what's the risk? Informed consent for complementary and integrative therapies. J Perinat Neonatal Nurs. 2010 Jul-Sep;24(3):201-4. doi: 10.1097/JPN.0b013e3181e8f930. No abstract available.
- Background: PubMed 30676461Dunn AB, Hanson L, VandeVusse L, Leslie S. Through the Microbial Looking Glass: Premature Labor, Preeclampsia, and Gestational Diabetes: A Scoping Review. J Perinat Neonatal Nurs. 2019 Jan/Mar;33(1):35-51. doi: 10.1097/JPN.0000000000000375.
- Background: PubMed 33315632Simonson J, Haglund K, Weber E, Fial A, Hanson L. Probiotics for the Management of Infantile Colic: A Systematic Review. MCN Am J Matern Child Nurs. 2021 Mar-Apr 01;46(2):88-96. doi: 10.1097/NMC.0000000000000691.
- Background: PubMed 32697544Malloy E, Kates A, Watson L, VandeVusse L, Safdar N, Hanson L. Laboratory Analysis Techniques for the Perinatal Microbiome: Implications for Studies of Probiotic Interventions. J Perinat Neonatal Nurs. 2020 Jul/Sep;34(3):239-250. doi: 10.1097/JPN.0000000000000496.
- Results publication: PubMed 36108911Hanson L, VandeVusse L, Forgie M, Malloy E, Singh M, Scherer M, Kleber D, Dixon J, Hryckowian AJ, Safdar N. A randomized controlled trial of an oral probiotic to reduce antepartum group B Streptococcus colonization and gastrointestinal symptoms. Am J Obstet Gynecol MFM. 2023 Jan;5(1):100748. doi: 10.1016/j.ajogmf.2022.100748. Epub 2022 Sep 13.
- Derived from this study: PubMed 39351987Hanson L, Albert K, Malloy E, Singh M, Kallay M, Brandt A, Morris C, Kleber D, Forgie M. Participant Personal Characteristics and Adherence to Oral Capsules: A Secondary Analysis of a Randomized Placebo-Controlled Trial of Antenatal Probiotics. J Midwifery Womens Health. 2025 May-Jun;70(3):452-459. doi: 10.1111/jmwh.13686. Epub 2024 Oct 1.
- Individual participant dataSharing planned: No
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Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
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.
Lisa C Hanson, PhD principal investigator
Marquette University, College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Florajen3 in people with Group B Streptococcus Carrier in Childbirth and Gastrointestinal Symptoms, run by Marquette University 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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 21 Mar 2024). 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?
Qualitative GBS Culture Result (time frame: 36 weeks gestation). 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 NCT03696953, which also lists 9 linked publications.
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 21 Mar 2024.