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A randomized controlled trial of an oral probiotic to reduce antepartum group B Streptococcus colonization and gastrointestinal symptoms.
Hanson, L, VandeVusse, L, Forgie, M, Malloy, E, Singh, M, Scherer, M, Kleber, D, Dixon, J, Hryckowian, AJ, Safdar, N
American journal of obstetrics & gynecology MFM. 2023;5(1):100748
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Plain language summary
Streptococcus agalactiae (or group B Streptococcus [GBS]) is an encapsulated, gram-positive, beta-haemolytic anaerobe that asymptomatically colonizes the genitourinary tract. Vertical transmission of GBS during normal vaginal birth can lead to neonatal colonization and risk for early-onset GBS disease. The aim of this study was to present the findings of a phase II, double-blind, randomised, placebo-controlled trial of an antenatal probiotic intervention to reduce GBS colonization. A secondary aim was to determine if the probiotic intervention reduces gastrointestinal (GI) symptoms of pregnancy. Participants (n=107) were randomly assigned to one of the two groups: probiotic intervention (n=55) or placebo group (n=54). Results show that: - there weren’t any significant differences between the groups in demographic characteristics, perinatal or neonatal outcomes, or intrapartum antibiotic prophylaxis doses. - there wasn’t any significant difference between groups in the presence of the probiotic bacteria on the rectal swabs, whereas the vaginal swabs showed a trend toward greater presence in probiotic group participants. - more probiotic participants took antenatal antibiotics (5/39) compared with controls (1/44). Authors conclude that probiotic bacteria colonisation of the genitourinary tract occurred more in the intervention group than in the control group and significantly reduced GI symptoms of pregnancy.
Abstract
BACKGROUND Probiotics have been suggested as a strategy to reduce antenatal group B Streptococcus colonization. Although probiotics are known to improve gastrointestinal symptoms, this has not been studied during pregnancy. OBJECTIVE This study aimed to evaluate the efficacy of a probiotic to reduce: (1) standard-of-care antenatal group B Streptococcus colonization and colony counts and (2) gastrointestinal symptoms of pregnancy. STUDY DESIGN In a double-blind fashion, 109 healthy adult pregnant people were randomized to Florajen3 probiotic or placebo capsules once daily from 28 weeks' gestation until labor onset. Baseline vaginal and rectal study swabs for group B Streptococcus colony-forming units and microbiome analysis were collected at 28 and 36 weeks' gestation. Standard-of-care vaginal to rectal group B Streptococcus swabs were collected from all participants at 36 weeks' gestation and determined the need for intrapartum antibiotic prophylaxis. Data collection included solicitation of adverse events, demographic information, Antepartum Gastrointestinal Symptom Assessment score, yogurt ingestion, sexual activity, and vaginal cleaning practices. RESULTS A total of 83 participants completed the study to 36 weeks' gestation with no adverse events. Standard-of-care group B Streptococcus colonization was 20.4% in the control group and 15.4% in probiotic group participants (-5%; P=.73). The relative risk for positive standard-of-care vaginal-rectal group B Streptococcus colonization was 1.33 (95% confidence interval, 0.5-3.40) times higher in the control group than in the probiotic group (P=.55). There were no differences in median vaginal (P=.16) or rectal (P=.20) group B streptococcus colony-forming units at baseline or at 36 weeks (vaginal P>.999; rectal P=.56). Antepartum Gastrointestinal Symptom Assessment scores were similar at baseline (P=.19), but significantly decreased in probiotic group participants at 36 weeks (P=.02). No covariates significantly altered group B Streptococcus colonization. Significantly more Florajen3 bacteria components were recovered from the vaginal-rectal samples of probiotic group participants (32%; P=.04) compared with controls. CONCLUSION The findings of this study provided insufficient evidence for the clinical application of the Florajen3 probiotic intervention to reduce standard-of-care vaginal-rectal group B Streptococcus colonization. The prevalence of group B Streptococcus was lower than expected in the study population, and intervention adherence was poor. Probiotic bacteria colonization of the genitourinary tract occurred more in intervention group participants than in controls and significantly reduced gastrointestinal symptoms of pregnancy.
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Probiotic interventions to reduce antepartum Group B streptococcus colonization: A systematic review and meta-analysis.
Hanson, L, VandeVusse, L, Malloy, E, Garnier-Villarreal, M, Watson, L, Fial, A, Forgie, M, Nardini, K, Safdar, N
Midwifery. 2022;:103208
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Abstract
OBJECTIVE To systematically review and meta-analyse studies of the efficacy of probiotics to reduce antenatal Group B Streptococcus (GBS) colonisation. PARTICIPANTS Antenatal participants with known positive GBS colonisation or unknown GBS status. INTERVENTION Probiotic interventions containing species of Lactobacillus or Streptococcus. DESIGN Systematic review and meta-analysis. MEASUREMENTS AND FINDINGS The systematic review included 10 studies. Five articles contained in vitro studies of probiotic interventions to determine antagonistic activity against GBS. Six clinical trials of probiotics to reduce antenatal GBS were systematically reviewed and meta-analysed. The meta-analysis revealed that the use of an antenatal probiotic decreased the probability of a positive GBS result by 44% (OR = 0.56, 95% CI = 8.7%, 194.1%, p = 0.02) (n = 709). However, only one clinical trial of 10 had a low risk of bias. KEY CONCLUSIONS The probiotic interventions subjected to in vitro testing showed antagonistic activity against GBS through the mechanisms of acidification, immune modulation, and adhesion. The findings of the meta-analysis of the clinical trials revealed that probiotics are a moderately effective intervention to reduce antenatal GBS colonisation. More well-controlled trials with diverse participants and with better elucidation of variables influencing GBS colonisation rates are needed. IMPLICATIONS FOR PRACTICE Probiotic interventions appear to be a safe and effective primary prevention strategy for antenatal GBS colonisation. Application of this low-risk intervention needs more study but may reduce the need for intrapartum antibiotic prophylaxis in countries or regions where antenatal GBS screening is used. Midwives can be instrumental in conducting and supporting larger well-controlled clinical trials.
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Through the Microbial Looking Glass: Premature Labor, Preeclampsia, and Gestational Diabetes: A Scoping Review.
Dunn, AB, Hanson, L, VandeVusse, L, Leslie, S
The Journal of perinatal & neonatal nursing. 2019;(1):35-51
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The influence of microbial factors on adverse perinatal outcomes has become the focal point of recent investigations, with particular interest in the role of the microbiome and probiotic interventions. The purpose of this scoping review was to identify and critique the most recent evidence about these factors as they relate to pregnancies complicated by preeclampsia (PEC), preterm birth (PTB), and gestational diabetes mellitus (GDM). Four databases (PubMed, EMBASE, Web of Science, and Cochrane) were searched for articles published in English in the last 10 years with the concepts of the microbiome, probiotics, and PEC, PTB, or GDM. Forty-nine articles were eligible for full-text review. Five articles were excluded, leaving 44 articles that met all the eligibility criteria. The relationships between the microbiome and the risk for PEC, PTB, and GDM are not fully elucidated, although probiotic interventions seem beneficial in decreasing PEC and GDM risk. Probiotic interventions targeting bacterial vaginosis and elimination of infection in women at risk for PTB appear to be beneficial. More research is needed to understand the contributions of the microbiome to adverse perinatal outcomes. Probiotic interventions appear to be effective in reducing risk for select outcomes.
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Effectiveness of CenteringPregnancy on Breastfeeding Initiation Among African Americans: A Systematic Review and Meta-analysis.
Robinson, K, Garnier-Villarreal, M, Hanson, L
The Journal of perinatal & neonatal nursing. 2018;(2):116-126
Abstract
While breastfeeding initiation rates for African American mothers are low, an innovative model of group prenatal care, CenteringPregnancy, holds promise to increase breastfeeding rates. The aim of this systematic review and meta-analysis was to examine the effects of CenteringPregnancy versus individual prenatal care on breastfeeding initiation among African American mothers. Using a systematic approach and PRISMA guidelines, 4 electronic databases were used to search the literature. English-language studies, comparing CenteringPregnancy and individual prenatal care, including African American participants, and specifying breastfeeding initiation as an outcome were screened for inclusion. Study strength and quality were assessed and 7 studies were systematically reviewed and meta-analyzed. Participation in CenteringPregnancy increased the probability of breastfeeding initiation by 53% (95% confidence interval = 29%-81%) (n = 8047). A subgroup analysis of breastfeeding initiation among only African American participants was performed on 4 studies where data were available. Participation in CenteringPregnancy increased the probability of breastfeeding initiation by 71% (95% confidence interval = 27%-131%) (n = 1458) for African American participants. CenteringPregnancy is an effective intervention to increase breastfeeding initiation for participants, especially for African Americans. To close the racial gap in breastfeeding initiation, high-quality research providing specific outcomes for African American participants in CenteringPregnancy are needed.
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Pilot Randomized Trial of Tacrolimus/Everolimus vs Tacrolimus/Enteric-Coated Mycophenolate Sodium in Adult, Primary Kidney Transplant Recipients at a Single Center.
Ciancio, G, Tryphonopoulos, P, Gaynor, JJ, Guerra, G, Sageshima, J, Roth, D, Chen, L, Kupin, W, Mattiazzi, A, Tueros, L, et al
Transplantation proceedings. 2016;(6):2006-10
Abstract
BACKGROUND Recent studies suggest that the combination of tacrolimus (TAC) and everolimus (EVL) could become a viable option for use as standard maintenance immunosuppression in non-highly sensitized kidney transplant recipients. METHODS We conducted a single-center, open-label, randomized pilot trial comparing two maintenance immunosuppression regimens in non-highly sensitized, adult, primary kidney transplant recipients: (TAC/EVL, Group A) vs our standard maintenance regimen of TAC plus enteric-coated mycophenolate mofetil (TAC/EC-MPS, Group B). In both treatment arms, dual induction therapy consisting of anti-thymocyte globulin (Thymoglobulin) and basiliximab was given. Early corticosteroid withdrawal (by 7-10 days posttransplantation) was also planned in both arms. There were 30 study participants, 15 per treatment arm. Results during the first 12 months posttransplantation are reported here. RESULTS Between 1 month and 12 months posttransplantation, mean TAC trough levels ranged between 5 and 8 ng/mL in both arms. Mean trough EVL level in Group A ranged between 4 and 6 ng/mL, and mean EC-MPS dose in Group B ranged from 1440 mg at 1 month to 945 mg at 12 months. One patient in Group A vs three patients in Group B experienced a first biopsy-proven acute rejection during the first 12 months posttransplantation (P = .32). Four patients in each group experienced biopsy-proven chronic allograft injury (interstitial fibrosis/tubular atrophy) (P = .99). There was a slight trend toward more favorable renal function in Group A at months 1-3 posttransplantation (P = .06, .10, and .18 for estimated glomerular filtration rate, respectively). No graft failures or deaths were observed in either group during the first 12 months posttransplantation. Four patients in each group developed an infection during the first 12 months posttransplantation. Two patients in Group A developed new-onset diabetes after transplant during the 12-month follow-up period, vs no patients in Group B (P = .13). CONCLUSION TAC/EVL may be a viable alternative to TAC/EC-MPS for use as standard maintenance immunosuppression in non-highly sensitized kidney transplant recipients and should be given further consideration.
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Probiotics for Treatment and Prevention of Urogenital Infections in Women: A Systematic Review.
Hanson, L, VandeVusse, L, Jermé, M, Abad, CL, Safdar, N
Journal of midwifery & women's health. 2016;(3):339-55
Abstract
INTRODUCTION Probiotics are a complementary and integrative therapy useful in the treatment and prevention of urogenital infections in women. This study extends the work of researchers who systematically investigated the scientific literature on probiotics to prevent or treat urogenital infections. METHODS A systematic review was conducted to determine the efficacy of probiotics for prevention and/or treatment of urogenital infections in adult women from January 1, 2008, through June 30, 2015. We searched in CINAHL, MEDLINE, Cochrane Central Register of Controlled Trials, Web of Science, Dissertations and Theses, and Alt-HealthWatch. After removing duplicates and studies that did not meet inclusion criteria, 20 studies were reviewed. All included at least one species of Lactobacillus probiotic as an intervention for treatment or prevention of urogenital infections. Data extracted included samples, settings, study designs, intervention types, reported outcomes, follow-up periods, and results. We evaluated all randomized controlled trials for risk of bias and made quality appraisals on all studies. RESULTS Fourteen of the studies focused on bacterial vaginosis (BV), 3 on urinary tract infections (UTIs), 2 on vulvovaginal candidiasis, and one on human papillomavirus (HPV) as identified on Papanicolaou test. Studies were heterogeneous in terms of design, intervention, and outcomes. Four studies were of good quality, 9 of fair, and 7 poor. Probiotic interventions were effective for treatment and prevention of BV, prevention of recurrences of candidiasis and UTIs, and clearing HPV lesions. No study reported significant adverse events related to the probiotic intervention. DISCUSSION The quality of the studies in this systematic review varied. Although clinical practice recommendations were limited by the strength of evidence, probiotic interventions were effective in treatment and prevention of urogenital infections as alternatives or co-treatments. More good quality research is needed to strengthen the body of evidence needed for application by clinicians.
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Feasibility of oral prenatal probiotics against maternal group B Streptococcus vaginal and rectal colonization.
Hanson, L, Vandevusse, L, Duster, M, Warrack, S, Safdar, N
Journal of obstetric, gynecologic, and neonatal nursing : JOGNN. 2014;(3):294-304
Abstract
OBJECTIVE To examine the effect of an oral prenatal probiotic on group B Streptococcus (GBS) colonization and to demonstrate the feasibility of a larger randomized controlled trial. DESIGN This pilot study was an open-label, two-group quasi-experiment. SETTING An urban central city nurse-midwifery and wellness center serving a diverse population. PARTICIPANTS Ten pregnant participants received the oral probiotic (Florajen3) taken once daily, and 10 participants served as controls. METHODS A questionnaire on dietary practices, vaginal cleansing, sexual history, and symptoms and GBS colony count samples were taken at 28-, 32-, and 36-weeks gestation. RESULTS Participants in the probiotic group reported no adverse events or minor side effects; one half reported improved gastrointestinal symptoms. Although two women in each group had positive qualitative prenatal GBS cultures at 36 weeks, the probiotic group participants had lower quantitative GBS colony counts. The eight GBS negative averaged 90% probiotic adherence compared with two GBS positive women who averaged 68%. Yogurt ingestion was inversely related (p = .02) to GBS colonization. CONCLUSIONS Prenatal probiotic therapy has the potential to reduce GBS colonization. The potential of the probiotic intervention appears to be linked to daily adherence. A controlled clinical trial with a larger, adequately powered sample is feasible and justified.
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Perinatal outcomes of prenatal probiotic and prebiotic administration: an integrative review.
VandeVusse, L, Hanson, L, Safdar, N
The Journal of perinatal & neonatal nursing. 2013;(4):288-301; quiz E1-2
Abstract
The purpose of this integrative review was to identify, critique, and synthesize the maternal and neonatal evidence on the prenatal use of probiotics and prebiotics to inform perinatal health professionals. A comprehensive literature search resulted in 37 studies of prenatal probiotics and 1 on antepartal prebiotics published from 1990 through 2011 that reported maternal, fetal, and/or neonatal outcomes. The methodologic quality of the studies reviewed was high, although investigators used different probiotic combinations and inconsistently reported perinatal clinical outcomes. The extraction of perinatal outcome variables resulted in identification of 9 maternal and 5 neonatal categories. Prenatal probiotics significantly reduced the incidence of bacterial vaginosis, increased colonization with vaginal Lactobacillus and intestinal Lactobacillus rhamnosus, altered immune markers in serum and breast milk, improved maternal glucose metabolism, and reduced the incidence of gestational diabetes and preeclampsia. Antepartally, probiotics were associated with significantly higher counts of Bifidobacterium and Lactococcus lactis (healthy intestinal flora) in neonatal stool. Prenatal prebiotics significantly increased maternal intestinal Bifidobacterium. No adverse events were reported and there was evidence of safety and tolerance of prenatal probiotics and prebiotics in the scientific investigations reviewed. It is recommended that in future investigations of prenatal probiotics researchers explicitly report maternal and neonatal outcomes.
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Randomized trial of dual antibody induction therapy with steroid avoidance in renal transplantation.
Ciancio, G, Gaynor, JJ, Sageshima, J, Guerra, G, Zarak, A, Roth, D, Brown, R, Kupin, W, Chen, L, Hanson, L, et al
Transplantation. 2011;(12):1348-57
Abstract
BACKGROUND Given our previous experience using dual-induction therapy with antithymocyte globulin (ATG)/daclizumab (Dac) (each with fewer doses than if used alone), we chose to compare two distinct dual-induction strategies. METHODS Single-center, open-label randomized trial of 200 primary kidney transplant recipients was performed: (group I, n=100) ATG/Dac (3 ATG, 2 Dac doses) versus (group II, n=100) ATG/alemtuzumab (1 dose each), with maintenance consisting of reduced tacrolimus dosing (rTd), enteric-coated mycophenolate sodium (EC-MPS), and early corticosteroid withdrawal. One half of standard EC-MPS dosing was targeted in group II to avoid severe leukopenia previously seen with alemtuzumab. The goal in both arms was to achieve rapid and effective lymphocyte depletion while simultaneously allowing reduced maintenance immunosuppression. Primary endpoint was the incidence of biopsy-proven acute rejection (BPAR). RESULTS With median follow-up of 38 months, there were no differences in BPAR rates: 14 of 100 vs. 13 of 100 (including borderline) and 10 of 100 vs. 9 of 100 (excluding borderline) in groups I and II, respectively (nonsignificant). Actuarial patient/graft survival at 48 months was 96%/91% in group I vs. 92%/83% in group II (N.S.). Mean estimated glomerular filtration rate (±standard error) at 36 months was 72.1±3.3 vs. 67.5±3.3 in groups I and II (N.S.). Greater incidence of leukopenia occurred in group II at month 1 only (P=0.002). Percentages having EC-MPS withheld/discontinued due to leukopenia, gastrointestinal symptoms, and infection were 12 of 100, 7 of 100, and 0 of 100 in group I vs. 19 of 100, 0 of 100, and 2 of 100 in group II, respectively (P=0.01). Rates of new onset diabetes mellitus after transplantation and infections were equally low in both groups (no lymphoproliferative disorders were observed). CONCLUSIONS These two distinct dual-induction therapies with rTd, EC-MPS, and planned early corticosteroid withdrawal resulted in favorable rates of BPAR and all secondary outcomes.
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Randomized trial of mycophenolate mofetil versus enteric-coated mycophenolate sodium in primary renal transplantation with tacrolimus and steroid avoidance: four-year analysis.
Ciancio, G, Gaynor, JJ, Zarak, A, Sageshima, J, Guerra, G, Roth, D, Brown, R, Kupin, W, Chen, L, Tueros, L, et al
Transplantation. 2011;(11):1198-205
Abstract
BACKGROUND Our single-center, open-labeled randomized trial of 150 adult, primary kidney transplant recipients receiving 2 g mycophenolate mofetil (group A, n=75) versus 1.440 g enteric-coated mycophenolate sodium (group B, n=75), with reduced maintenance tacrolimus dosing, steroid elimination at 1 week, and combined rabbit antithymocyte globulin/daclizumab induction, previously showed at 1 year posttransplant low biopsy-proven acute rejection (BPAR), acceptably high renal function, and no differences in incidence of symptomatic gastrointestinal (GI) side effects between the two groups. This report includes 3 additional years of follow-up with similar endpoints as in the original study. METHODS Rates of developing first BPAR, graft failure (death censored and uncensored), death, and adverse events (GI toxicity, infections requiring hospitalization, and new onset diabetes mellitus after transplantation) during the first 48 months posttransplant were compared between the two groups using an intent-to-treat approach. RESULTS At 48 months posttransplant, patient/graft survival in groups A and B was 97%/90% vs. 96%/86%, respectively (not significant [NS]). Twenty-seven patients experienced BPAR (including borderline), with actuarial 19% (14/75) vs. 18% (13/75) in groups A and B, respectively (NS). Geometric mean*/standard error serum creatinine level and arithmetic mean calculated glomerular filtration rate (±standard error) at 48 months in groups A and B, respectively, were 1.25*/1.06 and 69.2±3.9 vs. 1.20*/1.05 and 71.2±3.2 (NS). Incidence of new onset diabetes mellitus after transplantation (22% vs. 15%), infections requiring hospitalization (31% vs. 39%), and GI side effects (45% vs. 52%) seemed equivalent. CONCLUSIONS This is the first long-term, randomized trial comparing enteric-coated mycophenolate sodium versus mycophenolate mofetil along with reduced maintenance tacrolimus dosing and steroid avoidance, which resulted in similarly low-BPAR rates, acceptably high renal function at 48 months, and an equivalent side effect profile.