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Both treatment groups involve the use of accepted ingredients in infant nutrition and are manufactured in registered facilities that comply with Food Standards Australia and New Zealand guidelines with respect to manufacturing standards and compliance with food saftey requirements, including allergy management.
There are no known ingredients which might conceivably cause harm.
Where has the study received ethical approval?
Phase 1 of the study has received ethical approval from:
The Northern A Health and Disability Ethics Committee (Reference: 17/NTA/239)
What does being a part of this study include?
By being a part of this study you are agreeing to give your baby the required amount of kumara powder or probiotic control for a total of 6 months
Over the duration of the study you will be asked to participate in measurements at four time points
- Enrollment: when your baby is between 2 to 3 months of age
- Timepoint 1: when your baby is between 4 and 6 months of age (before you introduce any complementary foods)
- Timepoint 2: when your baby is 7 months of age
- Time point 3: when your baby is 12 months of age
What is the first food you’re using?
The whole food that we are interested in using is kumara which will be provided to participants in the form of a powder.
The kumara powder is to be mixed with water to form a paste. This is then added to any foods that you give your baby throughout the study. We hope that your baby will be able to consume 5 g (1 tsp) of kumara powder every day.
Kumara is a widely accepted food to be offered to infants as a first food. There are no perceivable risks associated with your baby consuming kumara.
What is the purpose of this study?
The purpose of this study is to examine the feasibility of conducting a randomised controlled trial (RCT) where we will assess the microbial impact of different whole foods during the complementary feeding period and the impact this has on immune health.
Why have I been invited to participate?
You have been invited to participate in this study because you are the parent or caregiver of a child who is currently between 2 to 3 months of age.
You also plan to introduce your child’s first complementary foods between 4 and 6 months of age (as per the Ministry of Health Food and Nutrition Guidelines).
What probiotic are we using?
The probiotic control that we will be using for those assigned to Group 2 will be Bifodobacterium Lactis.
This probiotic is commonly used in commercial infant formula and commercial infant products.
It has a good safety record for use in healthy infants.
A dose of 1X1010 CFU per day is commonly used in research in those infants who consume a probiotic enriched infant formula.
What if I no longer wish to participate in this study?
Taking part in this study is your choice and is completely voluntary.
You are free to withdraw your child at any time without having to explain why. Withdrawing from the study will not influence any future involvement you might have with the University of Auckland or the Liggin’s Institute.
Should you withdraw from the study, any information that has been previously collected will be retained to ensure that the results of the research project can be measured properly, unless you specifically ask for these to be removed.
Will I get any benefit from participating in this study?
Taking part in Phase 1 of this study will help us understand whether the study design is feasible for parents and caregivers like you to take part.
Your participation will also provide us with an understanding as to whether infants can consume the dietary intervention (kumara powder) in an amount that is sufficient to alter immune function through modifying gut bacteria.
You may also learn useful information on the complementary feeding period for your child and the role that gut microbiome plays in your child’s immune health.
Will taking part cost me anything or will I be paid?
Taking part in this study should not cost you anything more than your time.
Reserved parking will be available for all participants for pre-arranged clinic appointments.
If you experience difficulties getting to your clinic appointment, the research team will be able to make the necessary arrangements for you to attend.
The dietary intervention or probiotic control will be supplied to you at no cost.
Participants will receive a koha (gift) in the form of vouchers as an expression of thanks for dedicating time to this research.