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Relation
Karamali M, Nasiri N, Shavazi NT, et al. The Effects of Synbiotic Supplementation on Pregnancy Outcomes in Gestational Diabetes.Probiotics Antimicrobial proteins(published online ahead of print on August 7, 2017). doi: 10.1007/s12602-017-9313-7
Draft
Randomized, double-blind, placebo-controlled clinical trial
Participant
60 pregnant women in Iran aged 18 to 40 years with gestational diabetes who were not receiving oral antidiabetic medications; Exclusion criteria included preeclampsia, eclampsia, thyroid disease, tobacco use (smoking), kidney or liver disease, and current use of probiotics (including yogurt and kefir).
intervention
Participants were randomly assigned to consume 1 probiotic capsule or placebo every day for 6 weeks. The probiotic capsule contained the following ingredients:
- Lactobacillus acidophilus Stamm T16 (IBRC-M10785), 2 x 109 KBE/g
- Lactobacillus casei Stamm T2 (IBRC-M10783), 2 x 109 KBE/g
- Bifidobacterium bifidum Stamm T1 (IBRC-M10771), 2 x 109 KBE/g
- Inulin, 800 mg
All women in the study also consumed 400 mcg of folic acid per day from the start of pregnancy and 60 mg of ferrous sulfate per day from the second trimester onwards. Compliance and nutrition were monitored.
Study parameters assessed
All women and newborns were weighed and measured at baseline and at the end of the study (weight, length and head circumference for infants; height and weight for mothers). Fasting blood samples were collected at the beginning and end of treatment to determine serum levels of inflammatory markers and oxidative stress markers. Neonates were evaluated for hyperbilirubinemia (defined as total serum bilirubin ≥15 mg/dL for infants 25–48 hours of age, ≥18 mg/dL for infants 49–72 hours of age, and ≥20 mg/dL for infants older than 72 hours). . The infants' Apgar scores were also recorded.
Women were asked to record their food intake for 3 consecutive days in weeks 1, 3, and 5.
Primary outcome measures
Serum levels of inflammatory markers (C-reactive protein [CRP]) were the primary outcome measure; Secondary endpoints included oxidative stress biomarkers (nitric oxide [NO]total antioxidant capacity [TAC]total glutathione [GSH]malonaldehyde [MDA]) and pregnancy outcomes.
Key insights
After 6 weeks of treatment, there was no difference between groups in mean height, weight, or BMI. When reviewing the 3-day food diaries, there was no significant difference in macronutrient and micronutrient intake between groups.
After 6 weeks of intervention, women receiving probiotic supplementation had significantly reduced CRP compared to the placebo group (−1.9 ± 4.2 vs. +1.1 ± 3.5 mg/L;P=0.004), a marker of inflammation, and MDA, a marker of oxidative stress (−0.1 ± 0.6 vs. +0.3 ± 0.7 μmol/L;P=0.02). Total antioxidant capacity increased significantly (+70.1 ± 130.9 vs. -19.7 ± 124.6 mmol/L;P=0.009) as well as GSH (+28.7 ± 61.5 vs. -14.9 ± 85.3 umol/l;P=0.02). There was no detectable change in plasma NO levels in either group.
This study demonstrated several positive maternal and fetal effects of supplementation with a relatively low-dose probiotic in pregnant women with gestational diabetes.
Women in the supplementation group had significantly fewer cesarean sections (16.7% vs. 40.0%;P=0.04) and a lower incidence of hyperbilirubinemic newborns (3.3% vs. 30%;P=0.006) and neonatal hospitalization (3.3% vs. 30%;P=0.006) compared to the placebo group.
Practice implications
This study demonstrated several positive maternal and fetal effects of supplementation with a relatively low-dose probiotic in pregnant women with gestational diabetes. Positive impacts on mothers included improvements in biomarkers of inflammation and oxidative stress, as well as reduced need for higher-risk surgical procedures during labor. Positive effects on the babies included lower rates of jaundice and hospitalizations.
Previous studies of probiotics in other populations have shown positive effects on both inflammatory and oxidative biomarkers.1and studies in pregnant women with gestational diabetes have shown benefits in inflammatory markers.2Therefore, it is not surprising to see that probiotics could also improve oxidative biomarkers in this population of pregnant women.
Gestational diabetes is associated with increased oxidative stress due to increased production of reactive oxygen species and advanced glycosylated end products (AGEs).3This increase in oxidative stress can create an environment in which DNA, proteins, and lipids could be at greater risk for damage. This is particularly relevant during embryonic and fetal development, where high epigenetic imprinting occurs, which can be influenced by the oxidative environment and can also influence offspring into adulthood.
In addition, it has become clear that the maternal microbial environment is a key influencing factor on the development of the child's immune system, as shown by studies on the influence of the maternal microbiome on the atopic reaction of the offspring.4
This study and others point to the relevance of the maternal microbiome to pregnancy outcomes and offspring health. While we are beginning to understand the positive impacts, this is really just the beginning. In a few years, as increasing data point to clearer strain-specific effects on biomarkers and health parameters, we will likely look back to this time when prescribing a non-specific probiotic combination formula was crude. Nevertheless, the data clearly shows that this prescription can also bring benefits for mother and child.
restrictions
This study had some limitations that may be relevant. First, there were no fecal measurements of bacterial loads, short-chain fatty acids, or microbiological strain analysis. Since we know that individuals' microbiomes are unique, a better understanding of each participant's microbiome before and after the study period could have been helpful and also confirmed adherence to the protocol. Second, although this study is relevant to women with gestational diabetes, it would be helpful to understand possible beneficial effects on the general population through further study. Finally, given conflicting results on the effects on oxidative and inflammatory markers based on the symbiotic bacterial strains used, it will be helpful to examine the strain-specific effects so that the best probiotic strains can be applied to pregnant women.