title: Early pregnancy probiotic supplementation with Lactobacillus rhamnosus HN001 may reduce the prevalence of gestational diabetes mellitus: a randomised controlled trial.
abstract: The study aims to assess whether supplementation with the probiotic Lactobacillus rhamnosus HN001 (HN001) can reduce the prevalence of gestational diabetes mellitus (GDM). A double-blind, randomised, placebo-controlled parallel trial was conducted in New Zealand (NZ) (Wellington and Auckland). Pregnant women with a personal or partner history of atopic disease were randomised at 14-16 weeks' gestation to receive HN001 (6×109 colony-forming units) (n 212) or placebo (n 211) daily. GDM at 24-30 weeks was assessed using the definition of the International Association of Diabetes and Pregnancy Study Groups (IADPSG) (fasting plasma glucose ≥5·1 mmol/l, or 1 h post 75 g glucose level at ≥10 mmol/l or at 2 h ≥8·5 mmol/l) and NZ definition (fasting plasma glucose ≥5·5 mmol/l or 2 h post 75 g glucose at ≥9 mmol/l). All analyses were intention-to-treat. A total of 184 (87 %) women took HN001 and 189 (90 %) women took placebo. There was a trend towards lower relative rates (RR) of GDM (IADPSG definition) in the HN001 group, 0·59 (95 % CI 0·32, 1·08) (P=0·08). HN001 was associated with lower rates of GDM in women aged ≥35 years (RR 0·31; 95 % CI 0·12, 0·81, P=0·009) and women with a history of GDM (RR 0·00; 95 % CI 0·00, 0·66, P=0·004). These rates did not differ significantly from those of women without these characteristics. Using the NZ definition, GDM prevalence was significantly lower in the HN001 group, 2·1 % (95 % CI 0·6, 5·2), v. 6·5 % (95 % CI 3·5, 10·9) in the placebo group (P=0·03). HN001 supplementation from 14 to 16 weeks' gestation may reduce GDM prevalence, particularly among older women and those with previous GDM.
authors.affiliation: 1University of Otago,Wellington 6021,New Zealand.
authors.forename: Kristin L
authors.initials: KL
authors.lastname: Wickens
authors.affiliation: 1University of Otago,Wellington 6021,New Zealand.
authors.forename: Christine A
authors.initials: CA
authors.lastname: Barthow
authors.affiliation: 2University of Auckland,Auckland 1142,New Zealand.
authors.forename: Rinki
authors.initials: R
authors.lastname: Murphy
authors.affiliation: 1University of Otago,Wellington 6021,New Zealand.
authors.forename: Peter R
authors.initials: PR
authors.lastname: Abels
authors.affiliation: 4Victoria University,Wellington 6021,New Zealand.
authors.forename: Robyn M
authors.initials: RM
authors.lastname: Maude
authors.affiliation: 2University of Auckland,Auckland 1142,New Zealand.
authors.forename: Peter R
authors.initials: PR
authors.lastname: Stone
authors.affiliation: 2University of Auckland,Auckland 1142,New Zealand.
authors.forename: Edwin A
authors.initials: EA
authors.lastname: Mitchell
authors.affiliation: 1University of Otago,Wellington 6021,New Zealand.
authors.forename: Thorsten V
authors.initials: TV
authors.lastname: Stanley
authors.affiliation: 1University of Otago,Wellington 6021,New Zealand.
authors.forename: Gordon L
authors.initials: GL
authors.lastname: Purdie
authors.affiliation: 1University of Otago,Wellington 6021,New Zealand.
authors.forename: Janice M
authors.initials: JM
authors.lastname: Kang
authors.affiliation: 1University of Otago,Wellington 6021,New Zealand.
authors.forename: Fiona E
authors.initials: FE
authors.lastname: Hood
authors.affiliation: 2University of Auckland,Auckland 1142,New Zealand.
authors.forename: Judy L
authors.initials: JL
authors.lastname: Rowden
authors.affiliation: 1University of Otago,Wellington 6021,New Zealand.
authors.forename: Phillipa K
authors.initials: PK
authors.lastname: Barnes
authors.affiliation: 5Auckland Hospital,Auckland 1142,New Zealand.
authors.forename: Penny F
authors.initials: PF
authors.lastname: Fitzharris
authors.affiliation: 1University of Otago,Wellington 6021,New Zealand.
authors.forename: Julian
authors.initials: J
authors.lastname: Crane
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000378:metabolism*; D016640:Diabetes, Gestational / Q000097:blood / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D052201:Lacticaseibacillus rhamnosus; D009520:New Zealand / Q000453:epidemiology; D011247:Pregnancy; D015995:Prevalence; D019936:Probiotics / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose
keywords: 
                 Lactobacillus rhamnosus HN001;  Fonterra Fonterra Co-operative Group Ltd;  GDM gestational diabetes mellitus;  GTT glucose tolerance test;  HN001 Lactobacillus rhamnosus HN001;  IADPSG International Association of Diabetes and Pregnancy Study Group;  NZ New Zealand;  RR relative rate; Gestational diabetes mellitus; Probiotics; Randomised controlled trials