Effects of Probiotic Supplementation on Metabolic Status in Pregnant Women: a Randomized, Double-blind, Placebo-Controlled Trial
Authors: Mehri Jamilian
Zatollah Asemi
Shahrzad Hashemi Dizaji
Maryam Tajabadi-Ebrahimi
Zahra Vahedpoor
Ali Salmani
Fereshteh Bahmani
Parvaneh Jafari
Journal: Archives of Iranian Medicine (2016)
Discipline: CLINICAL MEDICINE
Keywords: multispecies probiotic supplementation; pregnant women; metabolic status; insulin resistance; inflammatory cytokines
Affiliations: Endocrinology and Metabolism Research Center, Department of Gynecology and Obstetrics, School of Medicine, Arak University of Medical Sciences, Arak, Iran., Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R. Iran., Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, I.R. Iran., Faculty Member of Science Department, Science Faculty, Islamic Azad University, Tehran Central branch, Tehran, Iran., Department of Microbiology, Science Faculty, Islamic Azad University, Arak Branch, Arak, Iran., Department of Gynecology and Obstetrics, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.

Abstract:  Background: Limited data is available on the effects of multispecies probiotic supplementation on metabolic status in pregnant women in the first half of pregnancy. The current study was carried out to determine the effects of multispecies probiotic capsule supplementation on metabolic status among pregnant women in the first half of pregnancy. Methods: A randomized clinical trial was conducted among 60 pregnant women aged 18-37 years. The participants were randomly divided into two groups: group A (n = 30) received multispecies probiotic supplements containing three probiotic bacteria spices Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum (2 × 109 CFU/g each) and group B (n = 30) received placebo from 9 weeks of gestation for a duration of 12 weeks. Fasting blood samples were taken at the beginning of the study and after 12 weeks of intervention to determine metabolic profiles, inflammatory cytokines and biomarkers of oxidative stress. Results: After 12 weeks of intervention, compared to the placebo group, the pregnant women who consumed probiotic capsule had significantly decreased serum insulin concentrations (-1.5 ± 4.8 vs. +1.3 ± 5.2 µIU/mL, P = 0.03), the homeostasis model of assessment-estimated insulin resistance (HOMA-IR) (-0.3 ± 0.9 vs. +0.3 ± 1.1, P = 0.04), the homeostasis model of assessment-estimated b cell function (HOMA-B) (-7.2 ± 23.1 vs. +5.3 ± 22.6, P = 0.03) and increased quantitative insulin sensitivity check index (QUICKI) (+0.01 ± 0.05 vs. -0.01 ± 0.02, P = 0.03). In addition, changes in serum triglycerides levels (-14.7 ± 46.5 vs. +37.3 ± 74.2 mg/dL, P = 0.002), high-sensitivity C-reactive protein (hs-CRP) (-1.0 ± 2.6 vs. +1.7 ± 4.3 mg/L, P = 0.004), plasma nitric oxide (NO) (+6.8 ± 9.3 vs. -4.7 ± 7.4 µmol/L, P &lt; 0.001), total antioxidant capacity (TAC) (+171.9 ± 187.6 vs. -51.9 ± 208.8 mmol/L, P &lt; 0.001) and glutathione (GSH) concentrations (+34.3 ± 71.6 vs. -36.9 ± 108.3 µmol/L, P = 0.004) in supplemented women were significantly different from those of the placebo group. However, after controlling for baseline levels, age and BMI at the study baseline, the changes in plasma GSH were not significantly different between the groups. Conclusion: Overall, probiotic supplementation for 12 weeks among pregnant women in the first half of pregnancy had beneficial effects on markers of insulin metabolism, triglycerides, biomarkers of inflammation and oxidative stress. 

Retracted: No

PubPeer comments:
 There are many concerns about the integrity of 172 publications by this research group, including this one. Some of the concerns are published 1. Anaesthesia 2020;75:1683u201392, see Supplementary data. This paper is A58 2. Account Res 2020;28:149-61. 3. J Clin Epidemiol 2021;131:22-29. Journals and publishers were notified of these concerns in July 2019. 23 publications have an expression of concern. To our knowledge there has been no public response about any of the concerns. We think these publications are unreliable ,