The effect of probiotic supplementation on the risk of gestational diabetes mellitus among high-risk pregnant women: A parallel double-blind, randomized, placebo-controlled clinical trial.

2021-09
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie 141

PubMed: 34328109
DOI: 10.1016/j.biopha.2021.111915

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 271
Population: pregnant women
Methods: double-blind, randomized, placebo-controlled clinical trial; pregnant women were randomized to either received probiotic supplement (n = 271) or placebo (n = 271) from 14 weeks of pregnancy up to 24 weeks; evaluated regarding GDM using a 75 g oral glucose tolerance test (OGTT)

Large Human Trial

Background

Based on a comprehensive search, we realized that the findings of the available literature are contradictory, and also limited data are available on Middle Eastern populations in terms of probiotic supplementation during the pregnancy. Therefore, the current double-blind, randomized, placebo-controlled clinical trial was carried out to investigate the effects of probiotic supplementation during pregnancy on the risk of gestational diabetes mellitus and also other maternal and neonatal outcomes.

Materials and methods

The pregnant women were randomized to either received probiotic supplement (n = 271) or placebo (n = 271) from the first half of the second trimester (14 weeks of pregnancy) up to 24 weeks when pregnant women routinely evaluated regarding the GDM. During the 24-28 weeks of pregnancy, mothers were evaluated regarding the presence of GDM using a 75 g oral glucose tolerance test (OGTT). The fasting blood glucose (FBG) was also evaluated within OGTT processes. Each 500 mg probiotic capsule was a mixture of Lactobacillus acidophilus LA1 (>7.5 × 10⁹ CFU), Bifidobacterium longum sp54 cs (>1.5 × 10⁹ CFU), and Bifidobacterium bifidum sp9 cs (>6 × 10⁹ CFU).

Results

Overall, 507 pregnant women make up our study population with a mean age of 32.03 years and a Body Mass Index (BMI) of 30.20 kg/m². There was no significant difference between the intervention and the control group regarding FBG (88.68 vs. 89.61 mg/dL; P = 0.338), OGTT-1h (163.86 vs. 166.88; mg/dL; P = 0.116), and OGTT-2h (138.39 vs. 139.27; mg/dL; P = 0.599). The incidence of GDM in the intervention group was 41.9% which was not significantly different from the control group (40.2%) (P = 0.780). Likewise, no significant difference was detected in terms of other studied parameters.

Conclusions

It seems that probiotics supplementation of pregnant women from the first half of the second trimester up to 24 weeks of pregnancy does not reduce the risk of GDM, or improve other neonatal and maternal outcomes.

Research Insights

Supplement	Dose	Health Outcome	Effect Type	Effect Size	Source
Bifidobacterium longum SP54	—	Reduced Fasting Blood Glucose Levels	Neutral	Small	View source There was no significant difference between the intervention and the control group regarding FBG (88.68 vs. 89.61 mg/dL; P = 0.338).
Bifidobacterium longum SP54	—	Reduced Postprandial Glucose Levels	Neutral	Small	View source There was no significant difference between the intervention and the control group regarding ... OGTT-1h (163.86 vs. 166.88; mg/dL; P = 0.116), and OGTT-2h (138.39 vs. 139.27; mg/dL; P = 0.599).
Bifidobacterium longum SP54	—	Reduced Prevalence of Gestational Diabetes Mellitus	Neutral	Small	View source The incidence of GDM in the intervention group was 41.9% which was not significantly different from the control group (40.2%) (P = 0.780).