Multi-strain Probiotic Increases the Gut Microbiota Diversity in Obese Pregnant Women: Results from a Randomized, Double-blind Placebo-controlled Study

Abstract

Background: Maternal obesity is associated with adverse pregnancy outcomes. Probiotic supplementation during pregnancy may have positive effects on blood glucose, gestational weight gain (GWG), and the risk of gestational diabetes mellitus (GDM). The primary aim was to determine the feasibility of probiotic intervention in obese pregnant women from the early second trimester until delivery. The secondary aim was to investigate the effect of daily probiotic supplementation on GWG, maternal glucose homeostasis, infant birthweight, and maternal gut microbiota. We carried out a randomized double-blinded placebo-controlled study in 50 obese pregnant women. Participants were randomly allocated to two treatment groups, multi-strain probiotic [Vivomixx®] or placebo at 14–20 weeks of gestation until delivery. Participants were followed with two pre-delivery visits at gestational week 27-30 and 36-37 and with one post-delivery visit 2-3 days after birth. All visits included blood and fecal sampling. An oral glucose tolerance test was performed at inclusion and gestational week 27-30. Results: Forty-nine participants completed the study. Thirty-eight participants took more than 80% of the Vivomixx® capsules (n=21), placebo (n=17). There was no significant difference in HbA1c levels and the occurrence of GDM between groups. There was no significant difference in GWG and infant birth weight between groups in intention to treat analysis. There was, however, a lower mean GWG (11.9 vs 13.0 kg) and lower mean infant birthweight (3554 vs 3658 g) in the probiotic group in the per protocol analysis, due to sample size this difference did not reach statistical significance. Fecal microbiota analyses showed an overall increase in α-diversity over time in the Vivomixx® group only (p=0.016). Conclusions: Administration of probiotics during pregnancy is feasible in obese women. Multi-strain probiotic can modulate the gut microbiota in obese women during pregnancy. A larger study population is needed to uncover whether the results regarding lower GWG and infant birth weight after probiotic supplementation are significant. Trial registration: ClincalTrials.gov Identifier: NCT02508844, registered on May 11, 2015.

Preventive effect of probiotics supplementation on occurrence of gestational diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials

“…One study included women with their or partner's history of atopic disease (20). Three studies included only overweight and obese participants (21, 26, 28), two studies evaluated only obese women (22,29), although five others didn't exclude women based on their BMI.…”

“…The intervention types are probiotics capsules in 8 studies, probiotic yogurt in one study (26) and probiotics sachet in another one (30). The frequency of intervention in most studies was once daily except for two studies which were twice a day (22,30). The dose of probiotics used in the studies varies.…”

“…Seven of them reported slightly larger infants in probiotic groups ranging from 10 g in the paper by Asgharian et al to 112 g in the paper by Louto et al, although these differences were not statistically significant (26, 32). Three researches looked on maternal weight gain during pregnancy (22,26,29). In two studies, women in the probiotics group gained more weight than those in the placebo group, despite the differences not being statistically significant (26, 29).…”

“…Selection bias, performance bias and attrition bias were not reported in any of the included studies. Allocation concealment was conducted in half of the studies (20, 26, 28, 29,31) and in four studies the outcome assessors were blinded (21,22,26,31). Moreover, one study was evaluated as high risk for selective outcome reporting (22).…”

“…Despite the existing systematic reviews and meta-analyses in order to assess the therapeutic effects of probiotics on pregnant women with GDM (18,19), there is a few systematic reviews and meta-analyses to determine whether probiotics could prevent the incidence of GDM in healthy pregnant women (20)(21)(22). Moreover, there is a need for evaluating the effect of probiotics supplementation on maternal and fetal consequences of GDM.…”