Hanieh Asgharian1, Aziz Homayouni-Rad2, Mojgan Mirghafourvand3, Sakineh Mohammad-Alizadeh-Charandabi4. 1. Students' Research Committee, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, IR, Iran. 2. Department of Food Science and Technology, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, IR, Iran. 3. Social Determinants of Health Research Center, Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, IR, Iran. 4. Research Center for Evidence-Based Medicine, Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Shariatie Ave., P.O. Box: 51745-347, Tabriz, IR, 513897977, Iran. alizades@tbzmed.ac.ir.
Abstract
INTRODUCTION: There is only some evidence about effectiveness of probiotics for preventing gestational hyperglycaemia. This trial examined the effects of probiotic yoghurts containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 on maternal plasma glucose (primary outcome) and on some maternal and infant complications (secondary outcomes) in overweight and obese women with no diabetes in pregnancy. METHODS: Using stratified block randomization, women with pre- or early-pregnancy BMI ≥ 25 and fasting plasma glucose < 92 mg/dl at 22 weeks of gestation were assigned into probiotic or conventional yoghurt group, consuming 100 g/day from 24 weeks of gestation until delivery. The women and their infants were followed up until 1 month after birth. RESULTS: In each group, one out of 65 women had intra-uterine foetal death and were not analysed for other outcomes. The mean BMI was 29.2 (SD 3.3) in probiotic and 30.3 (SD 4.1) in conventional yoghurt group. Four weeks after initiation of the treatment, plasma glucose levels were significantly lower in the probiotic than in conventional yoghurt group at fasting (mean difference adjusted for the BMI category) and baseline FPG (- 4.0 mg/dl; 95% confidence interval - 6.9, - 1.1) and 2-h OGTT (- 13.9; - 22.8, - 5.0). At the 1-h OGTT, however, the difference was not statistically significant (- 9.8; - 20.6, 0.9). Further, there was a significantly lower infant bilirubin level in the probiotic group on days 3-5 after birth (- 2.2 mg/dl; - 3.3, - 1.2). There were not statistically significant differences between the groups regarding the risk of gestational diabetes (6 vs 11; odds ratio 0.5; 0.2, 1.5), preterm delivery (3 vs 8; 0.3; 0.1, 1.2), and other maternal and infant outcomes. CONCLUSION: The probiotics supplementation has some beneficial effects on glucose metabolism of overweight and obese pregnant women. Nevertheless, further studies are required to judge the clinical significance of such effects.
RCT Entities:
INTRODUCTION: There is only some evidence about effectiveness of probiotics for preventing gestational hyperglycaemia. This trial examined the effects of probiotic yoghurts containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 on maternal plasma glucose (primary outcome) and on some maternal and infant complications (secondary outcomes) in overweight and obesewomen with no diabetes in pregnancy. METHODS: Using stratified block randomization, women with pre- or early-pregnancy BMI ≥ 25 and fasting plasma glucose < 92 mg/dl at 22 weeks of gestation were assigned into probiotic or conventional yoghurt group, consuming 100 g/day from 24 weeks of gestation until delivery. The women and their infants were followed up until 1 month after birth. RESULTS: In each group, one out of 65 women had intra-uterine foetal death and were not analysed for other outcomes. The mean BMI was 29.2 (SD 3.3) in probiotic and 30.3 (SD 4.1) in conventional yoghurt group. Four weeks after initiation of the treatment, plasma glucose levels were significantly lower in the probiotic than in conventional yoghurt group at fasting (mean difference adjusted for the BMI category) and baseline FPG (- 4.0 mg/dl; 95% confidence interval - 6.9, - 1.1) and 2-h OGTT (- 13.9; - 22.8, - 5.0). At the 1-h OGTT, however, the difference was not statistically significant (- 9.8; - 20.6, 0.9). Further, there was a significantly lower infantbilirubin level in the probiotic group on days 3-5 after birth (- 2.2 mg/dl; - 3.3, - 1.2). There were not statistically significant differences between the groups regarding the risk of gestational diabetes (6 vs 11; odds ratio 0.5; 0.2, 1.5), preterm delivery (3 vs 8; 0.3; 0.1, 1.2), and other maternal and infant outcomes. CONCLUSION: The probiotics supplementation has some beneficial effects on glucose metabolism of overweight and obese pregnant women. Nevertheless, further studies are required to judge the clinical significance of such effects.
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