The Probiotics in Pregnancy Study (PiP Study): rationale and design of a double-blind randomised controlled trial to improve maternal health during pregnancy and prevent infant eczema and allergy

BMC Pregnancy and Childbirth

Study Protocol

Gordon Purdie¹  Rinki Murphy²  Julian Crane³  Janice Kang³  Phillipa Barnes³  Fiona Hood³  Christine Barthow³  Kristin Wickens³  Peter Stone⁴  Peter Abels⁵  Thorsten Stanley⁶  Rebecca F. Slykerman⁷  Judy Rowden⁷  Edwin A. Mitchell⁷  Robyn Maude⁸  Penny Fitzharris⁹  Jeffrey Craig^1,10 

[1] Dean’s Department, University of Otago Wellington, PO Box 7343, 6242, Wellington South, New Zealand;Department of Medicine, University of Auckland, Private Bag 92019, 1142, Auckland, New Zealand;Department of Medicine, University of Otago Wellington, PO Box 7343, 6242, Wellington South, New Zealand;Department of Obstetrics and Gynaecology, University of Auckland, Private Bag 92019, 1142, Auckland, New Zealand;Department of Obstetrics and Gynaecology, University of Otago Wellington, PO Box 7343, 6242, Wellington South, New Zealand;Department of Paediatrics, University of Otago Wellington, PO Box 7343, 6242, Wellington South, New Zealand;Department of Paediatrics: Child and Youth Health, University of Auckland, Private Bag 92019, 1142, Auckland, New Zealand;Graduate School of Nursing, Midwifery and Health, Victoria University of Wellington, P O Box 7625, 6242, Newtown, Wellington, New Zealand;Immunology Department, Auckland Hospital, Private Bag 92024, Auckland Mail Centre, 1142, Auckland, New Zealand;Murdoch Children’s Research Institute, The Royal Children’s Hospital, Flemington Road, Parkville, 3052, Melbourne, Victoria, Australia;

关键词: Atopy;    Infant eczema;    Gestational diabetes;    Postpartum depression;    Pregnancy;    Probiotic;    Vaginal infections;   

DOI  :  10.1186/s12884-016-0923-y

 received in 2015-09-28, accepted in 2016-05-26,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundWorldwide there is increasing interest in the manipulation of human gut microbiota by the use of probiotic supplements to modify or prevent a range of communicable and non-communicable diseases. Probiotic interventions administered during pregnancy and breastfeeding offer a unique opportunity to influence a range of important maternal and infant outcomes.The aim of the Probiotics in Pregnancy Study (PiP Study) is to assess if supplementation by the probiotic Lactobacillus rhamnosus HN001 administered to women from early pregnancy and while breastfeeding can reduce the rates of infant eczema and atopic sensitisation at 1 year, and maternal gestational diabetes mellitus, bacterial vaginosis and Group B Streptococcal vaginal colonisation before birth, and depression and anxiety postpartum.Methods/designThe PiP Study is a two-centre, randomised, double-blind placebo-controlled trial in Wellington and Auckland, New Zealand. Four hundred pregnant women expecting infants at high risk of allergic disease will be enrolled in the study at 14–16 weeks gestation and randomised to receive either Lactobacillus rhamnosus HN001 (6 × 109 colony-forming units per day (cfu/day)) or placebo until delivery and then continuing until 6 months post-partum, if breastfeeding.Primary infant outcomes are the development and severity of eczema and atopic sensitisation in the first year of life. Secondary outcomes are diagnosis of maternal gestational diabetes mellitus, presence of bacterial vaginosis and vaginal carriage of Group B Streptococcus (at 35–37 weeks gestation). Other outcome measures include maternal weight gain, maternal postpartum depression and anxiety, infant birth weight, preterm birth, and rate of caesarean sections. A range of samples including maternal and infant faecal samples, maternal blood samples, cord blood and infant cord tissue samples, breast milk, infant skin swabs and infant buccal swabs will be collected for the investigation of the mechanisms of probiotic action.DiscussionThe study will investigate if mother-only supplementation with Lactobacillus rhamnosus HN001 in pregnancy and while breastfeeding can reduce rates of eczema and atopic sensitisation in infants by 1 year, and reduce maternal rates of gestational diabetes mellitus, bacterial vaginosis, vaginal carriage of Group B Streptococcus before birth and maternal depression and anxiety postpartum.Trial registrationAustralian New Zealand Clinical Trials Registration: ACTRN12612000196842.Date Registered: 15/02/12.

【 授权许可】

CC BY   
© The Author(s). 2016