InfectionNCT01479478
Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy
A study testing Probiotic dietary supplement in people with Infection and Pregnancy, run by Stanford University at 3 sites in United States.
Trial summary
The investigators wish to determine if oral probiotic supplementation during the second half of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational age, thereby decreasing need for maternal antibiotic administration at time of labor. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- What is being tested?
- Probiotic dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2011to 26 Jul 2017
- Phase
- Interventional
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women between 20-28 weeks gestation.
- 18 years of age or older.
- Singleton gestation.
Who cannot join
- Preexisting morbidity: Immunocompromised status (HIV +; malignancy; history of organ transplant; chronic steroid therapy; autoimmune disease requiring treatment during pregnancy, and other immunocompromised states); Type 1 diabetes and type 2 diabetes;congenital cardiac disease and cardiac valvular disease requiring antibiotic prophylaxis during procedure/labor; pulmonary disease (except mild asthma); renal disease; chronic hepatic disease (Hepatitis B, C); inflammatory bowel disease (Crohn's disease or ulcerative colitis); stomach or duodenal ulcer; bowel resection, gastric bypass, and chronic indwelling venous, bladder, or gastric catheter.
- Multi-fetal gestation.
- Use of probiotics preparations in the 3 months prior to beginning of the study treatment or use of any additional probiotics preparations (other than study treatment) at any time during the study period (including over the counter food supplements such as Activia, BioK, other oral or vaginal probiotics products (BUT not including other common forms of yogurt).
- Chronic (daily) use of broad spectrum antibiotics.
- History of infant with GBS sepsis.
- Intrauterine Growth Restriction (IUGR), Fetal Anomalies-major diagnosed at time of second trimester anatomy ultrasound
- Anticipated delivery <35 wks for maternal/fetal indication
- Placenta previa or accreta (with anticipated delivery prior to 35 weeks)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Aptos Women's Health Center
Aptos, California, 95003
Dominican Hospital
Santa Cruz, California, 95065
Stanford University School of Medicine/Lucile Packard Children's Hospital
Stanford, California, 94305
About this study
Official title: Oral Probiotic Supplementation and Group B Streptococcus Rectovaginal Colonization in Pregnant Women: a Randomized Double-blind Placebo-controlled Trial.
The investigators wish to determine if oral probiotic supplementation during the second half of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational age, thereby decreasing need for maternal antibiotic administration at time of labor. The importance of this study is that it may offer a safer alternative to antibiotic treatment of group B Streptococcus (GBS) colonized pregnant women.
Read the detailed description
- Screening: All pregnant women prior to 28 weeks gestational age. Patients who choose to enroll and who will not deliver at Lucile Packard Childrens Hospital at Stanford will sign release of medical information forms for study personnel to access pregnancy outcomes. Patients receiving obstetric care at any of the satellite research sites in Santa Cruz will also be offered enrollment in the study.
- Women will continue regular and routine obstetric care and clinic visits.
- Placebo vs probiotic daily regimen: We plan to begin administration of product and placebo at 20 weeks gestation, and no later than 28 weeks gestation until delivery. Once a women is enrolled in the study, she will be randomized to either the placebo or the probiotic group.
- At the time of randomization, the patient will receive her month supply of 30 capsules; The allocation arm will be double-blinded.
- The investigators will schedule the women for routine monthly obstetric visits (more often if clinically required) during which time they will also meet with one of the investigators. The investigator at each monthly visit will provide an additional monthly allotment of 30 capsules. The capsule bottle from the previous cycle will be collected and dated if there are capsules remaining in the bottle. Remaining capsules will be counted and refrigerated for future use.
- The investigators will collect history data including safety data per the questionnaire and will document compliance with the study.
- GBS recto-vaginal screening: The investigators will enroll the women in the study and we will perform the standard GBS colonization screening (using standard GBS recto-vaginal cultures) at 36 weeks.
- Additionally, subjects may opt to have serial vaginal swabs collected to assess potential beneficial effects of probiotics on the vaginal microbiota and bacterial vaginosis (BV) status. Vaginal swabs will be collected (either by study personnel or self-collected by the study participant). Swabs will be inserted 1-2 inches into the vaginal introitus and spun for 20 seconds and then withdrawn. Swabs will be collected at the following time points: prior to probiotic/placebo initiation, every 1-4 weeks from time of enrollment to time of delivery, and postpartum serially up to 12 months. These swabs will be stored at -20 degrees Celsius or colder for additional microbiologic analyses.
- Additionally, placental tissue may be collected at time of delivery for possible future microbiome and/or other analyses.
- Women who suffer a premature rupture of the membranes, deliver before 36 weeks gestation, or go into labor before the GBS culture result is available, will receive the standard GBS antibiotic prophylaxis.
- Labor: The patient will receive standard delivery and newborn care. Patients with a positive GBS culture will be treated with standard antibiotics in labor.
- Postpartum and neonatal care: The patient will receive routine postpartum care per the obstetric team. Data regarding her postpartum course and neonatal outcomes will be collected.
- Being tested
- Placebo, Probiotic dietary supplement
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Sugar pill
One placebo capsule daily.
Probiotic dietary supplementDietary supplement
Also called Other Names:, Jarrow's fem-dophilus
Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
| Study group | Role | What they receive |
|---|---|---|
| Probiotic dietary supplement | Active comparator | Probiotic dietary supplement one capsule once per day until delivery. Receives: Dietary Supplement: Probiotic dietary supplement |
| Placebo | Placebo comparator | Placebo capsule, one daily until delivery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age
Gestational age is given in a format of full weeks.
Measured: 35 to 37 weeks gestational age
Secondary outcomes (17)
Count of Participants With Urinary Tract Infection
Measured: From enrollment up to delivery hospitalization (up to 42 weeks gestation)
Count of Participants With Intrapartum Chorioamnionitis
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.
Measured: From time of labor onset until delivery (up to 42 weeks of gestation)
Count of Participants With Endometritis
Endometritis is a uterine (myometrial) infection.
Measured: From time of delivery up to 6 weeks postpartum
Count of Participants With Cellulitis
Cellulitis is a bacterial skin infection.
Measured: From time of delivery up to 6 weeks postpartum
Count of Participants With Bacteremia
Bacteremia is defined as presence of bacteria in the blood.
Measured: From time of labor onset up to 6 weeks postpartum
Count of Participants With Sepsis
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated response of the body to an infection.
Measured: From labor onset up to 6 weeks postpartum
Count of Participants With Other Infectious Morbidity
Other infectious morbidity included maternal mastitis or pneumonia.
Measured: From time of labor onset up to 6 weeks postpartum
Gestational Age at Delivery
Gestational age at delivery is presented as weeks.
Measured: At time of delivery (up to 42 weeks of gestation)
Apgar Score at 1 and 5 Minutes Following Delivery
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.
Measured: At time of delivery (up to 42 weeks of gestation)
Neonatal Bilirubin Level
Measured: Up to 14 days following delivery
Neonatal C-reactive Protein Level
Maximum neonatal C-reactive protein level
Measured: Up to 14 days following delivery
Count of Neonates Requiring a "Rule-out Sepsis Evaluation"
Outcome was based on performance of neonatal blood culture.
Measured: Up to 14 days following delivery
Count of Neonates With Sepsis
Measured: Up to 14 days following delivery
Count of Neonates With Pneumonia
Measured: Up to 14 days following delivery
Count of Neonates With Meningitis
Measured: Up to 14 days following delivery
Count of Neonates With Intensive-care Unit Admission
Measured: Up to 14 days following delivery
Length of Neonatal Hospital Stay
Measured: Up to 14 days following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startNov 2011
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
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.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natali Aziz, Stanford University
- Investigators
- Natali Aziz, MD, Principal investigator, Stanford University School of Medicine/Lucile Packard Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479478
- Sponsor's protocol ID
- 18840
- Status last verified
- Aug 2018
- First submitted
- 22 Nov 2011
- Last updated
- 20 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Probiotic Supplementation and Group B Streptococcus Rectovaginal Colonization in Pregnant Women: a Randomized Double-blind Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT01479478
- Acronym / sponsor ID
- 18840
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Posted 20 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators wish to determine if oral probiotic supplementation during the second half of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational age, thereby decreasing need for maternal antibiotic administration at time of labor. The importance of this study is that it may offer a safer alternative to antibiotic treatment of group B Streptococcus (GBS) colonized pregnant women.
Detailed description
- Screening: All pregnant women prior to 28 weeks gestational age. Patients who choose to enroll and who will not deliver at Lucile Packard Childrens Hospital at Stanford will sign release of medical information forms for study personnel to access pregnancy outcomes. Patients receiving obstetric care at any of the satellite research sites in Santa Cruz will also be offered enrollment in the study.
- Women will continue regular and routine obstetric care and clinic visits.
- Placebo vs probiotic daily regimen: We plan to begin administration of product and placebo at 20 weeks gestation, and no later than 28 weeks gestation until delivery. Once a women is enrolled in the study, she will be randomized to either the placebo or the probiotic group.
- At the time of randomization, the patient will receive her month supply of 30 capsules; The allocation arm will be double-blinded.
- The investigators will schedule the women for routine monthly obstetric visits (more often if clinically required) during which time they will also meet with one of the investigators. The investigator at each monthly visit will provide an additional monthly allotment of 30 capsules. The capsule bottle from the previous cycle will be collected and dated if there are capsules remaining in the bottle. Remaining capsules will be counted and refrigerated for future use.
- The investigators will collect history data including safety data per the questionnaire and will document compliance with the study.
- GBS recto-vaginal screening: The investigators will enroll the women in the study and we will perform the standard GBS colonization screening (using standard GBS recto-vaginal cultures) at 36 weeks.
- Additionally, subjects may opt to have serial vaginal swabs collected to assess potential beneficial effects of probiotics on the vaginal microbiota and bacterial vaginosis (BV) status. Vaginal swabs will be collected (either by study personnel or self-collected by the study participant). Swabs will be inserted 1-2 inches into the vaginal introitus and spun for 20 seconds and then withdrawn. Swabs will be collected at the following time points: prior to probiotic/placebo initiation, every 1-4 weeks from time of enrollment to time of delivery, and postpartum serially up to 12 months. These swabs will be stored at -20 degrees Celsius or colder for additional microbiologic analyses.
- Additionally, placental tissue may be collected at time of delivery for possible future microbiome and/or other analyses.
- Women who suffer a premature rupture of the membranes, deliver before 36 weeks gestation, or go into labor before the GBS culture result is available, will receive the standard GBS antibiotic prophylaxis.
- Labor: The patient will receive standard delivery and newborn care. Patients with a positive GBS culture will be treated with standard antibiotics in labor.
- Postpartum and neonatal care: The patient will receive routine postpartum care per the obstetric team. Data regarding her postpartum course and neonatal outcomes will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic dietary supplement | Active comparator | Dietary Supplement: Probiotic dietary supplementProbiotic dietary supplement one capsule once per day until delivery. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule, one daily until delivery. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women between 20-28 weeks gestation.
- 18 years of age or older.
- Singleton gestation.
Key exclusion criteria (8 listed)
- Preexisting morbidity: Immunocompromised status (HIV +; malignancy; history of organ transplant; chronic steroid therapy; autoimmune disease requiring treatment during pregnancy, and other immunocompromised states); Type 1 diabetes and type 2 diabetes;congenital cardiac disease and cardiac valvular disease requiring antibiotic prophylaxis during procedure/labor; pulmonary disease (except mild asthma); renal disease; chronic hepatic disease (Hepatitis B, C); inflammatory bowel disease (Crohn's disease or ulcerative colitis); stomach or duodenal ulcer; bowel resection, gastric bypass, and chronic indwelling venous, bladder, or gastric catheter.
- Multi-fetal gestation.
- Use of probiotics preparations in the 3 months prior to beginning of the study treatment or use of any additional probiotics preparations (other than study treatment) at any time during the study period (including over the counter food supplements such as Activia, BioK, other oral or vaginal probiotics products (BUT not including other common forms of yogurt).
- Chronic (daily) use of broad spectrum antibiotics.
- History of infant with GBS sepsis.
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 |
|---|---|---|
| PlaceboAlso: Sugar pillOne placebo capsule daily. | Drug | Placebo |
| Probiotic dietary supplementAlso: Other Names:, Jarrow's fem-dophilusDietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14 | Dietary supplement | Probiotic dietary supplement |
Primary outcome
Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age
Time frame: 35 to 37 weeks gestational age
Gestational age is given in a format of full weeks.
17 secondary outcomes
Count of Participants With Urinary Tract Infection
Time frame: From enrollment up to delivery hospitalization (up to 42 weeks gestation)
Count of Participants With Intrapartum Chorioamnionitis
Time frame: From time of labor onset until delivery (up to 42 weeks of gestation)
Count of Participants With Endometritis
Time frame: From time of delivery up to 6 weeks postpartum
Count of Participants With Cellulitis
Time frame: From time of delivery up to 6 weeks postpartum
Count of Participants With Bacteremia
Time frame: From time of labor onset up to 6 weeks postpartum
Count of Participants With Sepsis
Time frame: From labor onset up to 6 weeks postpartum
Count of Participants With Other Infectious Morbidity
Time frame: From time of labor onset up to 6 weeks postpartum
Gestational Age at Delivery
Time frame: At time of delivery (up to 42 weeks of gestation)
Apgar Score at 1 and 5 Minutes Following Delivery
Time frame: At time of delivery (up to 42 weeks of gestation)
Neonatal Bilirubin Level
Time frame: Up to 14 days following delivery
Neonatal C-reactive Protein Level
Time frame: Up to 14 days following delivery
Count of Neonates Requiring a "Rule-out Sepsis Evaluation"
Time frame: Up to 14 days following delivery
Count of Neonates With Sepsis
Time frame: Up to 14 days following delivery
Count of Neonates With Pneumonia
Time frame: Up to 14 days following delivery
Count of Neonates With Meningitis
Time frame: Up to 14 days following delivery
Count of Neonates With Intensive-care Unit Admission
Time frame: Up to 14 days following delivery
Length of Neonatal Hospital Stay
Time frame: Up to 14 days following delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Natali Aziz, MD principal investigator
Stanford University School of Medicine/Lucile Packard Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic dietary supplement in people with Infection and Pregnancy, run by Stanford University at 3 sites 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 3 inclusion and 8 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2018). 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?
Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age (time frame: 35 to 37 weeks gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2018.