SPRING: an RCT study of probiotics in the prevention of gestational diabetes mellitus in overweight and obese women

BMC Pregnancy and Childbirth, Feb 2013

Background Obesity is increasing in the child-bearing population as are the rates of gestational diabetes. Gestational diabetes is associated with higher rates of Cesarean Section for the mother and increased risks of macrosomia, higher body fat mass, respiratory distress and hypoglycemia for the infant. Prevention of gestational diabetes through life style intervention has proven to be difficult. A Finnish study showed that ingestion of specific probiotics altered the composition of the gut microbiome and thereby metabolism from early gestation and decreased rates of gestational diabetes in normal weight women. In SPRING (the Study of Probiotics IN the prevention of Gestational diabetes), the effectiveness of probiotics ingestion for the prevention of gestational diabetes will be assessed in overweight and obese women. Methods/design SPRING is a multi-center, prospective, double-blind randomized controlled trial run at two tertiary maternity hospitals in Brisbane, Australia. Five hundred and forty (540) women with a BMI > 25.0 kg/m2 will be recruited over 2 years and receive either probiotics or placebo capsules from 16 weeks gestation until delivery. The probiotics capsules contain > 1x109 cfu each of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12 per capsule. The primary outcome is diagnosis of gestational diabetes at 28 weeks gestation. Secondary outcomes include rates of other pregnancy complications, gestational weight gain, mode of delivery, change in gut microbiome, preterm birth, macrosomia, and infant body composition. The trial has 80% power at a 5% 2-sided significance level to detect a >50% change in the rates of gestational diabetes in this high-risk group of pregnant women. Discussion SPRING will show if probiotics can be used as an easily implementable method of preventing gestational diabetes in the high-risk group of overweight and obese pregnant women.

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SPRING: an RCT study of probiotics in the prevention of gestational diabetes mellitus in overweight and obese women

Marloes Dekker Nitert 0 1 Helen L Barrett 0 1 Katie Foxcroft 2 Anne Tremellen 6 Shelley Wilkinson 5 6 Barbara Lingwood 1 Jacinta M Tobin 4 Chris McSweeney 3 Peter O'Rourke 8 H David McIntyre 7 Leonie K Callaway 0 2 0 School of Medicine, The University of Queensland , Herston , Australia 1 The UQ Centre for Clinical Research, The University of Queensland , RBWH campus, Butterfield street, Herston QLD 4029 , Australia 2 The Royal Brisbane and Women's Hospital , Herston , Australia 3 CSIRO , St Lucia , Australia 4 Western Clinical School, The University of Melbourne , Melbourne , Australia 5 Department of Nutrition & Dietetics, Mater Mothers' Hospital , Brisbane , Australia 6 Mater Medical Research Institute, Mothers' & Babies Theme , South Brisbane , Australia 7 Mater Clinical School, The University of Queensland , South Brisbane , Australia 8 Statistics Unit, Queensland Institute of Medical Research , Herston , Australia Background: Obesity is increasing in the child-bearing population as are the rates of gestational diabetes. Gestational diabetes is associated with higher rates of Cesarean Section for the mother and increased risks of macrosomia, higher body fat mass, respiratory distress and hypoglycemia for the infant. Prevention of gestational diabetes through life style intervention has proven to be difficult. A Finnish study showed that ingestion of specific probiotics altered the composition of the gut microbiome and thereby metabolism from early gestation and decreased rates of gestational diabetes in normal weight women. In SPRING (the Study of Probiotics IN the prevention of Gestational diabetes), the effectiveness of probiotics ingestion for the prevention of gestational diabetes will be assessed in overweight and obese women. Methods/design: SPRING is a multi-center, prospective, double-blind randomized controlled trial run at two tertiary maternity hospitals in Brisbane, Australia. Five hundred and forty (540) women with a BMI > 25.0 kg/m2 will be recruited over 2 years and receive either probiotics or placebo capsules from 16 weeks gestation until delivery. The probiotics capsules contain > 1x109 cfu each of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12 per capsule. The primary outcome is diagnosis of gestational diabetes at 28 weeks gestation. Secondary outcomes include rates of other pregnancy complications, gestational weight gain, mode of delivery, change in gut microbiome, preterm birth, macrosomia, and infant body composition. The trial has 80% power at a 5% 2-sided significance level to detect a >50% change in the rates of gestational diabetes in this high-risk group of pregnant women. Discussion: SPRING will show if probiotics can be used as an easily implementable method of preventing gestational diabetes in the high-risk group of overweight and obese pregnant women. - Background The incidence of gestational diabetes mellitus (GDM), diabetes mellitus first diagnosed during pregnancy, is on the rise in concordance with the rise in overweight and obesity in the obstetric population [1]. GDM is associated with short term and long term morbidity for mother and baby. In the short term, women with GDM have an increased risk of developing preeclampsia and delivery by Cesarean section [2,3]. For the infant, maternal GDM increases the risk of excessive adiposity, macrosomia (a birth weight of >4000 g), shoulder dystocia, admittance to the neonatal intensive care unit and neonatal hypoglycemia [4,5]. In the long term, maternal GDM is associated with increased risk of obesity as well as metabolic (type 2 diabetes) and cardiovascular disease in both mother and baby [6-8]. While current therapy, which is focused on normalizing blood glucose levels, is variably successful in reducing the short term complications of GDM, this may not be true for the longer term complications [9]. Therefore, prevention of GDM would be preferable. The incidence of GDM is higher in women who are overweight or obese prior to falling pregnant [10]. Strategies for the prevention of GDM have until now been restricted to diet and exercise interventions, which have had mixed results [11,12]. Many of these trials have had small sample sizes and their methodological heterogeneity complicates comparability. Additionally, there are substantial barriers to pregnant women engaging in intensive lifestyle intervention programs [13,14]. The role of the gut microbiome as a modulator of metabolic and inflammatory process is currently being investigated. The gut microbiome is the composite of bacterial species present in the gut. Many factors influence the exact gut microbiome species composition in adult life including antibiotic therapy in early life [15], growth and inhibitory factors determined by diet, host and microbial factors as well as luminal pH, osmolarity and organism replication rates [16]. Gut microbiome species have discrete capabilities in generating energy for take-up by the host. The gut microbiome (...truncated)


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Marloes Dekker Nitert, Helen L Barrett, Katie Foxcroft, Anne Tremellen, Shelley Wilkinson, Barbara Lingwood, Jacinta M Tobin, Chris McSweeney, Peter O’Rourke, H David McIntyre, Leonie K Callaway. SPRING: an RCT study of probiotics in the prevention of gestational diabetes mellitus in overweight and obese women, BMC Pregnancy and Childbirth, 2013, pp. 50, 13, DOI: 10.1186/1471-2393-13-50