title: Probiotics in obese pregnancy do not reduce maternal fasting glucose: a double-blind, placebo-controlled, randomized trial (Probiotics in Pregnancy Study).
abstract: BACKGROUND
  Recent studies have reported beneficial effects of probiotics on maternal glycemia in healthy pregnant women. Obesity significantly increases risk of impaired glucose tolerance in pregnancy, but glycemic effects of probiotics in this specific obstetric group require additional investigation.
  
  
  OBJECTIVE
  The aim of the Probiotics in Pregnancy Study was to investigate the effect of a probiotic capsule on maternal fasting glucose in obese pregnant women.
  
  
  METHODS
  In this placebo-controlled, double-blind, randomized trial, 175 pregnant women with an early pregnancy body mass index (BMI; in kg/m²) from 30.0 to 39.9 were recruited from antenatal clinics at the National Maternity Hospital, Dublin, Ireland. Exclusion criteria were BMI <30.0 or >39.9, prepregnancy or gestational diabetes, age <18 y, multiple pregnancy, and fetal anomaly. Women were randomly assigned to receive either a daily probiotic or a placebo capsule from 24 to 28 wk of gestation in addition to routine antenatal care. The primary outcome was the change in fasting glucose between groups from preintervention to postintervention. Secondary outcomes were the incidence of gestational diabetes and neonatal anthropometric measures.
  
  
  RESULTS
  In 138 women who completed the study (63 women in the probiotic group; 75 women in the placebo group), mean (±SD) early pregnancy BMI was 33.6 ± 2.6, which differed significantly between probiotic (32.9 ± 2.4) and placebo (34.1 ± 2.7) groups. With adjustment for BMI, the change in maternal fasting glucose did not differ significantly between treated and control groups [-0.09 ± 0.27 compared with -0.07 ± 0.39 mmol/L; P = 0.391; B = -0.05 (95% CI: -0.17, 0.07)]. There were also no differences in the incidence of impaired glycemia (16% in the probiotic group compared with 15% in the placebo group; P = 0.561), birth weight (3.70 kg in the probiotic group compared with 3.68 kg in the placebo group; P = 0.723), or other metabolic variables or pregnancy outcomes. A secondary analysis of 110 women, excluding antibiotic users and poor compliers, also revealed no differences in maternal glucose or other outcomes between groups.
  
  
  CONCLUSIONS
  Probiotic treatment of 4 wk during pregnancy did not influence maternal fasting glucose, the metabolic profile, or pregnancy outcomes in obese women.
authors.affiliation: From the University College Dublin (UCD) Obstetrics and Gynaecology, School of Medicine and Medical Science, UCD, National Maternity Hospital, Dublin, Ireland (KLL, MK, and FMM); Laboratory Medicine, National Maternity Hospital, Dublin, Ireland (MC); the Department of Clinical Chemistry, St Vincent's University Hospital, Elm Park, Dublin, Ireland (TS and OCM); the Department of Medicine, Alimentary and Pharmabiotic Centre, University College Cork, Cork, Ireland (FS); and the Institute of Food and Health, UCD School of Agriculture and Food Science, UCD, Belfield, Dublin, Ireland (LB).
authors.forename: Karen L
authors.initials: KL
authors.lastname: Lindsay
authors.affiliation: From the University College Dublin (UCD) Obstetrics and Gynaecology, School of Medicine and Medical Science, UCD, National Maternity Hospital, Dublin, Ireland (KLL, MK, and FMM); Laboratory Medicine, National Maternity Hospital, Dublin, Ireland (MC); the Department of Clinical Chemistry, St Vincent's University Hospital, Elm Park, Dublin, Ireland (TS and OCM); the Department of Medicine, Alimentary and Pharmabiotic Centre, University College Cork, Cork, Ireland (FS); and the Institute of Food and Health, UCD School of Agriculture and Food Science, UCD, Belfield, Dublin, Ireland (LB).
authors.forename: Maria
authors.initials: M
authors.lastname: Kennelly
authors.affiliation: From the University College Dublin (UCD) Obstetrics and Gynaecology, School of Medicine and Medical Science, UCD, National Maternity Hospital, Dublin, Ireland (KLL, MK, and FMM); Laboratory Medicine, National Maternity Hospital, Dublin, Ireland (MC); the Department of Clinical Chemistry, St Vincent's University Hospital, Elm Park, Dublin, Ireland (TS and OCM); the Department of Medicine, Alimentary and Pharmabiotic Centre, University College Cork, Cork, Ireland (FS); and the Institute of Food and Health, UCD School of Agriculture and Food Science, UCD, Belfield, Dublin, Ireland (LB).
authors.forename: Marie
authors.initials: M
authors.lastname: Culliton
authors.affiliation: From the University College Dublin (UCD) Obstetrics and Gynaecology, School of Medicine and Medical Science, UCD, National Maternity Hospital, Dublin, Ireland (KLL, MK, and FMM); Laboratory Medicine, National Maternity Hospital, Dublin, Ireland (MC); the Department of Clinical Chemistry, St Vincent's University Hospital, Elm Park, Dublin, Ireland (TS and OCM); the Department of Medicine, Alimentary and Pharmabiotic Centre, University College Cork, Cork, Ireland (FS); and the Institute of Food and Health, UCD School of Agriculture and Food Science, UCD, Belfield, Dublin, Ireland (LB).
authors.forename: Thomas
authors.initials: T
authors.lastname: Smith
authors.affiliation: From the University College Dublin (UCD) Obstetrics and Gynaecology, School of Medicine and Medical Science, UCD, National Maternity Hospital, Dublin, Ireland (KLL, MK, and FMM); Laboratory Medicine, National Maternity Hospital, Dublin, Ireland (MC); the Department of Clinical Chemistry, St Vincent's University Hospital, Elm Park, Dublin, Ireland (TS and OCM); the Department of Medicine, Alimentary and Pharmabiotic Centre, University College Cork, Cork, Ireland (FS); and the Institute of Food and Health, UCD School of Agriculture and Food Science, UCD, Belfield, Dublin, Ireland (LB).
authors.forename: Orla C
authors.initials: OC
authors.lastname: Maguire
authors.affiliation: From the University College Dublin (UCD) Obstetrics and Gynaecology, School of Medicine and Medical Science, UCD, National Maternity Hospital, Dublin, Ireland (KLL, MK, and FMM); Laboratory Medicine, National Maternity Hospital, Dublin, Ireland (MC); the Department of Clinical Chemistry, St Vincent's University Hospital, Elm Park, Dublin, Ireland (TS and OCM); the Department of Medicine, Alimentary and Pharmabiotic Centre, University College Cork, Cork, Ireland (FS); and the Institute of Food and Health, UCD School of Agriculture and Food Science, UCD, Belfield, Dublin, Ireland (LB).
authors.forename: Fergus
authors.initials: F
authors.lastname: Shanahan
authors.affiliation: From the University College Dublin (UCD) Obstetrics and Gynaecology, School of Medicine and Medical Science, UCD, National Maternity Hospital, Dublin, Ireland (KLL, MK, and FMM); Laboratory Medicine, National Maternity Hospital, Dublin, Ireland (MC); the Department of Clinical Chemistry, St Vincent's University Hospital, Elm Park, Dublin, Ireland (TS and OCM); the Department of Medicine, Alimentary and Pharmabiotic Centre, University College Cork, Cork, Ireland (FS); and the Institute of Food and Health, UCD School of Agriculture and Food Science, UCD, Belfield, Dublin, Ireland (LB).
authors.forename: Lorraine
authors.initials: L
authors.lastname: Brennan
authors.affiliation: From the University College Dublin (UCD) Obstetrics and Gynaecology, School of Medicine and Medical Science, UCD, National Maternity Hospital, Dublin, Ireland (KLL, MK, and FMM); Laboratory Medicine, National Maternity Hospital, Dublin, Ireland (MC); the Department of Clinical Chemistry, St Vincent's University Hospital, Elm Park, Dublin, Ireland (TS and OCM); the Department of Medicine, Alimentary and Pharmabiotic Centre, University College Cork, Cork, Ireland (FS); and the Institute of Food and Health, UCD School of Agriculture and Food Science, UCD, Belfield, Dublin, Ireland (LB).
authors.forename: Fionnuala M
authors.initials: FM
authors.lastname: McAuliffe
mesh_terms: D000328:Adult; D015992:Body Mass Index; D015331:Cohort Studies; D016640:Diabetes, Gestational / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D018149:Glucose Intolerance / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D006771:Hospitals, Maternity; D006801:Humans; D006943:Hyperglycemia / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D015994:Incidence; D007494:Ireland / Q000453:epidemiology; D007778:Lactobacillus; D039382:Maternal Nutritional Physiological Phenomena; D009765:Obesity / Q000097:blood / Q000178:diet therapy* / Q000503:physiopathology; D010044:Outpatient Clinics, Hospital; D011247:Pregnancy; D011248:Pregnancy Complications / Q000097:blood / Q000178:diet therapy* / Q000503:physiopathology; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D012306:Risk