Effects of probiotics (Vivomixx®) in obese pregnant women and their newborn: study protocol for a randomized controlled trial

Abstract

BackgroundMaternal obesity is associated with increased risks of adverse pregnancy-related complications and outcomes for both mothers and infants. Overweight and obese women have an increased risk of pregnancy-induced hypertension, preeclampsia and gestational diabetes mellitus (GDM). Infant Body Mass index (BMI) and the risk of obesity in adulthood are related to maternal gestational weight gain (GWG). Preventive lifestyle and dietary interventions are time-consuming and do not always reduce GWG or the risk of maternal pregnancy complications. Recent research has indicated that the gut microbiota may play a significant role in the development of obesity. Some studies have indicated that the daily consumption of probiotics may reduce the risk of preeclampsia, maintain serum insulin levels and reduce the frequency of GDM in pregnant women. The aims of this study are to investigate whether daily probiotic supplements in obese women during pregnancy can limit gestational weight gain, improve glucose homeostasis and thereby improve maternal, fetal and infant health outcomes.MethodsA pilot study including 50 obese pregnant nulliparous women with a prepregnancy BMI of between 30 and 35 kg/m2 will be randomized to receive daily probiotics (four capsules of Vivomixx®; total of 450 billion CFU/day, including eight probiotic bacterial strains) or placebo from gestational age 14–20 weeks until delivery. The infants will be followed until 9 months of age. The women will be monitored by weight, blood, fecal, vaginal and urine samples, diet questionnaires and hospital record review. Primary outcomes are: maternal weight gain, glycated hemoglobin (HbA1c) level and changes in glucose concentration measured during an oral glucose tolerance test. Secondary outcomes are: microbiota and inflammatory markers in mother and child, pregnancy complications, pregnancy outcomes, physical activity and the body composition of the neonate.DiscussionWe expect to find alterations in the metabolic profiles, microbiota and possibly pregnancy outcomes. From a clinical point of view the effects of Vivomixx® could control weight gain and reduce complications during pregnancy by inducing changes in the gut microbiota. Furthermore, this intervention during pregnancy could influence the infant’s microbiota, which could have important implications for infant development and health.Trial registrationClincalTrials.gov Identifier: NCT02508844, registered on 11 May 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1617-5) contains supplementary material, which is available to authorized users.

A Review on Role of Microbiome in Obesity and Antiobesity Properties of Probiotic Supplements

“…bulgaricus DSM 24734, L. acidophilus DSM 24735, L. paracasei DSM 24733, and L. plantarum DSM 24730; 4.5 × 10 10 CFU in total) from 14-20 weeks of gestation until the delivery of the baby. After the detailed analysis of blood, urine, fecal samples, and diet profile and weight gain, it has been proved that the supplementation of Vivomixx® significantly reduced the weight gain during the pregnancy period and reduced the pregnancy complications via positive alteration of GM of obese pregnant women [31].…”

Probiotics for the Treatment of Overweight and Obesity in Humans—A Review of Clinical Trials

“…Supplementation with L. rhamnosus GG and B. lactis ( per day) from the first-trimester pregnancy up to 6 months after delivery in combination with a diet can counteract obesity and reduce metabolic disorders [ 75 ]. Additionally, the study showed long-term benefits and safety associated with the intervention used, among others reducing the risk of GDM in women at high risk [ 76 , 123 ]. On the other hand, there was no effect of L. salivarius UCC118 ( CFU per day) on body weight during four-week supplementation in women in the first trimester of pregnancy [ 77 ].…”

Probiotics in pregnancy: protocol of a double-blind randomized controlled pilot trial for pregnant women with depression and anxiety (PIP pilot trial)

“…c A rate of intake ≥ 80% is similar to other (pilot) RCTs with probiotics and food supplements in pregnant and non-pregnant individuals [34, 35]…”

“… a In case one or more progression criteria are not met, revisions to the study protocol should be considered prior to conducting the full randomized controlled trial (RCT) b A rate > 90% is comparable to previous RCTs in pregnant women with depressive and anxiety symptoms [32, 33] c A rate of intake ≥ 80% is similar to other (pilot) RCTs with probiotics and food supplements in pregnant and non-pregnant individuals [34, 35] d The rates of adherence to vaginal and fecal sampling and hair-sampling protocols do not include unforeseen errors, for example, loss of biological samples due to storage problems, etc*Key progression criteria…”