We want to find out if by giving pregnant women a specific probiotic we can:
- Stop infants developing eczema and allergy
- Help pregnant women's health by preventing:
- Some vaginal infections
- A type of diabetes that occurs only in pregnancy (gestational diabetes)
What are probiotics?
Probiotics are helpful microbes that occur naturally in many foods such as yoghurt. They provide health benefits.
What does the study involve?
- Participants in this study need to take one study capsule each day starting when 14-16 weeks pregnant and continuing throughout the remainder of their pregnancy and for 6 months after birth while breast feeding.
- Half the participants will take study capsules containing the study probiotic. They contain one specific probiotic strain which is not genetically modified and was produced in a Halal compliant manner.
- The other half of the participants will receive study capsules that do not contain probiotics. These capsules are called a “placebo”. The placebo capsules contain Maltodextran only instead of the probiotic.
- Neither you nor the researchers know who is having the probiotic capsules and who is having the placebo until after the study is completed.
- After birth the baby would not receive the study capsules.
- Participants will take part in 5-6 study visits starting when they are 14-16 weeks pregnant and finishing when their baby is 1 year old.
- Study visits involve a range of questions and measures including one set of blood tests and two sets of vaginal swabs during pregnancy. We will also be testing participants, their baby and the baby's father for allergies and checking your baby's skin for eczema.
- We will provide parking and petrol vouchers when participants need to travel to attend study visits. Home visits will be arranged for some parts of the study (e.g. just after birth).
Who can take part in this study?
Women taking part in the study need to:
1. Be less than 16 weeks pregnant
2. Either they (the pregnant woman) or the biological father of the unborn child must have had eczema, asthma or hay fever that was treated by a doctor at some time in the past
3. Live in, and plan to deliver in the Wellington area
Live in, and plan to deliver in the Auckland area
If you are unsure if you would meet all of the above criteria please contact us.
Please note: A range of other criteria apply to women who wish to join the study.
These will be assessed over the phone by the research staff after women register interest in the study.
What are the benefits of taking part in this study?
Being involved in this study means that:
- You may be healthier during pregnancy (although there is no guarantee of this).
- Your child may not develop eczema (although there is no guarantee of this).
- You would be contributing to important research which may help us to gain new ways of preventing illnesses in pregnancy and in young children
Who is conducting this study?
This research is being conducted in two centres, (Wellington and Auckland), and is being run by a group of experienced researchers collaborating across several different institutions. Several members of this group have successfully completed a similar large scale research using probiotics in pregnancy women and infants in the past.
- Dr Kristin Wickens, Epidemiologist (a)
- Professor Julian Crane, Director Wellington Asthma Research Group (a)
- Dr Thorsten Stanley, Senior Lecturer and Consultant Paediatrician (a,c)
- Dr Peter Abels, Senior Lecturer and Consultant Obstetrician (a,c)
- Dr Robyn Maude, Midwife, Lecturer Graduate School of Nursing, Midwifery and Health, and Associate Director of Midwifery (b,c)
- Ms Christine Barthow, Research Fellow/Nurse (a)
- Mr Gordon Purdie, Biostatistician/Senior Research Fellow (a)
(a) University of Otago
(b) Victoria University of Wellington
(c) Capital and Coast District Health Board
- Professor Edwin Mitchell, Professor of Child Health Research (d)
- Professor Peter Stone, Professor of Maternal Fetal Medicine (d)
- Dr Penelope Fitzharris, Clinical Director, Immunology Dept (e)
(d) Auckland University
(e) Auckland City Hospital
Ethics & Funding
This study has received ethics approval through the Multi-region Ethic Committee and is primarily funded by the Health Research Council of New Zealand.
If you are interested in this study please express your interest today,
or for further information contact:
Phone: (04) 918 6889
Text: 022 3172546
Phone: (09) 923 3979
Text: 021 1045343
Please note with certain browsers, the PDF Viewer may have problems displaying fonts, colours or the whole document. If this happens please follow the below instructions to view these files:
- Click the download button on the right side of the document header in order to open it with the default PDF program on your computer.
- Study brochure (contains most of the information on this web page)
- Further information on this study & other previous research in this area (Background to Probiotics Study)
- Published scientific papers of probiotic research completed by investigators:
- Eczema prevention trial
A differential effect of 2 probiotics in the prevention of eczema and atopy
A protective effect of Lactobacillus rhamnosus HN001 against eczema in the first 2 years of life persists to age 4 years
- Eczema treatment trial
Is the effect of probiotics on atopic dermatitis confined to food sensitized children?
- Methods paper describing the protocol and procedures used in the Probiotics in Pregnancy Study
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
- Gestational diabetes and probiotics
Early pregnancy probiotic supplementation with Lactobacillus rhamnosus HN001 may reduce the prevalence of gestational diabetes mellitus: a randomised controlled trial
- Eczema prevention trial