Early pregnancy probiotic supplementation with Lactobacillus rhamnosus HN001 may reduce the prevalence of gestational diabetes mellitus: a randomised controlled trial

The British Journal of Nutrition
Q1
Mar 2017
Citations:138
Influential Citations:9
Interventional (Human) Studies
88
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Enhanced Details

Methods
Two-centre, double-blind, randomised, placebo-controlled parallel trial conducted in Auckland and Wellington, NZ. Pregnant women with a personal or partner history of atopic disease enrolled at 14-16 weeks' gestation; 423 participants randomised (HN001 n=212; placebo n=211); intention-to-treat analyses.
Intervention
Lactobacillus rhamnosus HN001, 6 × 10^9 CFU per day, taken in capsules from enrolment at 14-16 weeks' gestation through pregnancy and until 6 months postpartum if breastfeeding.
Results
GDM prevalence by NZ thresholds was lower with HN001 (2.1% vs 6.5%; P=0.03; 95% CI 0.6–5.2 and 3.5–10.9 respectively). Under IADPSG criteria, overall reduction was not statistically significant (RR 0.59; 95% CI 0.32–1.08; P=0.08). Subgroup analyses showed stronger protection in older women (≥35 years; RR 0.31; 95% CI 0.12–0.81; P=0.009) and in women with prior GDM (RR 0.00; 95% CI 0.00–0.66; P=0.004). The protective effect was more evident among those not using antibiotics during enrolment-to-GTT. Early-pregnancy HN001 may reduce GDM risk, particularly in higher-risk groups; high adherence and no major safety concerns were reported; further trials are warranted to confirm.
Limitations
No pre-pregnancy anthropometric data; reliance on enrolment measures for weight/waist changes; power based on Finnish trial estimates may overstate detectable effect; antibiotic use during enrolment-to-GTT (interactions observed; limited power for interactions); incomplete GTT data for some participants; generalizability may be limited by self-selected NZ population and diagnostic thresholds; missing data were handled with imputation.

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...