A research study for newborns with a family history of allergy

The study aims to investigate whether the new special formula:

• Alters the composition of gut flora and thereby reduces allergy development in children with a family history of allergy.

Participants in the study will be divided into three different groups:

• A group that receives the study formula – the newly developed hypoallergenic formula containing partially hydrolysed proteins together with specific prebiotics (fibres) and probiotics (beneficial gut bacteria).
• A group that receives the control formula – a standard formula containing intact proteins with no prebiotics or probiotics.
• A group that receives breastmilk only without any additional formula for at least 16 weeks.

Both the study formula and the control formula are appropriate to your child’s age and contain all the necessary ingredients and meet the requirements for optimal infant nutrition.

Nutricia Research has been studying human milk for over forty years. We share our expertise to support and educate healthcare professionals on infant and maternal nutrition.

Human milk is the best source of nourishment for infants worldwide. Breastfeeding has numerous known benefits for infants and mothers alike, both over the short and long term. Our research strives to further investigate and support breastfeeding, with human milk as our inspiration to innovate.

Pregnant and lactating women, infants, elderly and patients of all ages with special nutritional needs deserve nutritional support. Nutricia Research uses life science, food science, technology and the drive and expertise of over 600 employees to deliver nutritional products to those with special needs.

About Nutricia Research

Nutricia Research is a global research and development organisation. As part of the Danone corporation, our Early Life Nutrition and Advanced Medical Nutrition divisions contribute to our global mission to deliver health through food to as many people as possible. Our research and innovation areas have evolved, but we still begin with insights into nutrients and their role in optimal health, and build on that knowledge to tailor solutions for nutritional needs throughout the lifespan of our target populations.

See www.nutriciaresearch.com for more information

What is a clinical study?

• A clinical study is a scientific study of how a new or existing medicine, product, procedure or treatment works in people. This study will look at the effectiveness of an infant formula.
• Through clinical studies, doctors can find new and better ways to prevent, detect, diagnose, control and treat illnesses.
• All clinical studies are carefully monitored and regulated to ensure participant well-being.
• Participating in a clinical study is completely voluntary and will not affect the normal standard of care your child receives.

Why is this study being done?

This study aims to examine a new infant formula to see whether it can alter the gut flora and thereby reduce the occurrence of allergies. We will compare allergy development in babies whose father, mother or siblings have an allergy. They will receive either the hypoallergenic study formula or the standard infant formula.

What will the study involve?

 Your child will participate up to the age of around 54 weeks (just over one year).

• You will have to visit the doctor’s office five times during the study and you will also have two scheduled telephone calls. During the doctor’s appointments your infant’s general health and growth will be monitored and samples will be collected.
• Samples that will be taken from your child during the study consist of blood, saliva, nose swabs and stool. You will also be asked to record in an electronic diary your child’s stool frequency and consistency, occurrence of vomiting, feeding habits and any allergies.
• Your child will join around 700 other healthy babies from various countries who have also been invited to take part in this study.

How will the study work?

• You can join this study if you plan to exclusively breastfeed your child or if you plan to start an infant formula before your child is 16 weeks of age.
• If you intend to breastfeed only, then you and your child can join the breastfeeding group immediately.
• If you wish to supplement your breastfeeding with infant formula or to switch to infant formula completely, a formula will be supplied.
• You will then be supplied with one of the following two formulas:
  • Formula 1 – the study formula
  • Formula 2 – the control formula
• Your child will be randomly assigned (meaning by chance, like a coin toss) to one of these two formula groups. This is called randomisation. Neither you nor the study team will know which formula your child has been given. However, if medically necessary, this information can be provided.
• The infant formula will be supplied to you free of charge.
• Throughout the TEMPO Study, the study team will remain committed to your child’s well-being and will always be happy to answer any questions you may have.

What do I need to know?

• Your child will receive one of the two infant formulas at no cost to you.
• Your child will be monitored closely throughout the study.
• It is essential that you and your child go to all the study appointments.
• You can withdraw your child from the TEMPO Study at any time and for any reason. This will not affect the standard of care your child receives.
• You can talk to the study team at any time about any questions or concerns you may have.