Background
Aims and hypotheses
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To examine changes in microbiota and inflammatory markers in mother and child (in fecal samples)
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To examine changes in vaginal microbiological profile and frequency of urinary tract infections (including group B streptococcus infections)
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To examine changes in concentrations of lipids and inflammatory markers (maternal blood sample)
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To assess if the intervention reduces the risk of complications during pregnancy and at birth – including GDM, preeclampsia, gestational hypertension, change in the mode of delivery, gestational age, macrosomia (birth weight of over 4000 g) and large- and small-for-gestational-age infants
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To examine the impact of the intervention on diet, physical activity levels and breastfeeding
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To examine differences in the neonatal outcome – weight, z-score, Apgar score after 5 min, umbilical cord pH, and the risk of early neonatal transfer to the neonatal intensive care unit
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To assess the child’s weight gain and body composition until 9 months of age (dual-energy X-ray absorptiometry (DEXA) scanning (at birth) and skin-fold measurements thereafter)
Methods
Study design
Recruitment of participants
Inclusion criteria
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Aged over 18 years
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Prepregnancy BMI ≥30 and <35 kg/m2
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Nulliparous singleton pregnancy
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Ability to read and speak Danish
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Normal ultrasound scan of the fetus at gestational age 12–14 weeks
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Oral glucose tolerance test (OGTT) at gestational age 14–20 weeks
Exclusion criteria
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Pregnancy at over 20 weeks’ gestation at recruitment
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Pregestational diabetes or other serious diseases
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Multiple pregnancy
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Previous bariatric surgery
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Ingestion of probiotics more than 1 month before the inclusion or ingestion of probiotics other than the study probiotics
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Alcohol or drug abuse
Randomization procedure
Study agent
Data handling and record keeping
Assessment of primary outcomes
Measurement | Inclusion/randomization (14–20 weeks) | 27–30 weeks | 36–37 weeks | Delivery | 1–3 days after delivery | 3 months after delivery | 6 months after delivery | 9 months after delivery |
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Baseline questionnaire | X | |||||||
Diet questionnaire | X | X | ||||||
Weight (pregnant/mother) | X | X | X | X | X | X | X | |
Blood sample (pregnant/mother) | X | X | X | X | X | X | ||
Blood pressure | X | X | X | |||||
Fecal sample (pregnant/mother) | X | X | X | X | X | X | X | |
Urine sample + vaginal swab | X | X | X | |||||
Pedometer | X | X | X | |||||
OGTT | X | X | ||||||
Fecal sample – infant | X | X | X | X | ||||
Urine sample – infant | X | X | X | X | ||||
Newborn – umbilical cord blood sample | X | |||||||
DEXA scanning | X | |||||||
Breast milk sample | X | X | X | X | ||||
Newborn/child physical examination and anthropometric data | X | X | X | X | ||||
Question about urinary tract infections | X | X | X | |||||
Question about colic symptoms, breastfeeding, allergy and atopic dermatitis | X | X | X |