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.
Highlights
Maternal obesity is associated with increased risks of adverse pregnancy-related complications and outcomes for both mothers and infants
Aims and hypotheses In a pilot study of 50 obese pregnant women, we aim to investigate if the probiotic Vivomixx® can affect gestational weight gain, glycated hemoglobin (HbA1c) level and reduce impairment of glucose tolerance at gestational weeks 27–30, compared to weeks 14–20, in obese pregnant women
In summary, previous studies in pregnant obese women state that obesity in pregnancy is associated with adverse outcomes for both mothers and infants, including the risk for pregnancy-induced hypertension, preeclampsia, gestational diabetes mellitus (GDM) and macrosomia
Summary
Study design In this single-center, double-blind, randomized, placebocontrolled pilot study, 25 obese pregnant women will be treated with probiotics and 25 will be treated with placebo. Included pregnant women will receive two capsules of the probiotic mixture Vivomixx® or placebo twice daily from gestational weeks 14–20 until delivery. Examination including blood, urine, vaginal and fecal sampling will be performed at gestational weeks 14–20 (baseline), 27–30 and 36–37 in all study participants. Other measures Questionnaires Participants in the study will complete a questionnaire at the time of inclusion about demographic data including smoking history, educational level, and data about prepregnancy physical activity. Urine samples Urine samples are collected at home by the participant on the morning that they attend the study visit. Sample size and statistics This is the first pilot study in which the probiotic Vivomixx® is added in a randomized fashion to the standard of care in obese pregnant women. For planning of the final study the significance level for the outcomes will be set at P < 0.1 to select the relevant outcome measurements
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