Join us to ensure that nutritious
formula is available to American families
Every mom should have access to premium nutrition for their baby. Bubs Australia wants to work with you to make it happen. If you’re an expecting mom (35 weeks+) or have an infant younger than 14 days old, you may be eligible for our clinical study.
To determine if you are eligible to join the study, we need to ask you a few questions. In just a few minutes you can find out if you are eligible to join. This questionnaire will help us better understand you and your pregnancy, and determine if this study is right for you and your baby.
Why join this study?
By participating you’ll play a vital role in ensuring moms and babies for generations to come have clean and nutritious formula options. Additionally, you’ll receive:
● Infant formula for up to 6 months at no cost
● Up to $300 in compensation for your time
● In-clinic supervised study visits with doctors who are experts in baby care
● Easy to use app from home or while visiting a local provider
How do I participate?
Participation is easy. All daily study check-ins can be completed from your home, and your baby’s growth will be measured by a trained doctor or nurse at their office to provide the best possible care. Our team of professionals will be available to answer questions throughout the study.
- FILL OUT THIS FORM
Click Apply Now and complete the form. If you are eligible, you will receive immediate notification and an email with instructions to schedule your first appointment.
- FEED YOUR BABY
If eligible, you will receive one of three study products or a well-known existing organic cow milk infant formula.
- MEASURE GROWTH
On a scheduled basis, you will visit a study doctor to have your baby’s growth measured and to check on your baby’s progress over 16 weeks.
If you have any questions, please contact the study team at firstname.lastname@example.org.
Find out if you are eligible to join the study.
It only takes a few minutes to find out if you are eligible to join. These quick questions will help us to determine if this study is right for you and your baby.
How Does The Study Work?
Complete the pre-screening questionnaire
If you are eligible, you will receive immediate notification and an email with instructions to schedule your first appointment.
Receive all formula at your chosen study site
Based on random selection (like flipping a coin), we’ll provide one of the three study products or a well-known existing cow milk infant formula at no cost. You will receive it immediately upon your baby’s enrollment visit, and at each follow up visit throughout the study.
Feeding your baby
During the 16-week study period you will feed your baby only the provided formula. For the formula feeding group, no breastfeeding or other formula is allowed.
Measure growth and formula intake
On a scheduled basis (every 2 to 4 weeks), you will visit the study doctor to measure your baby’s weight, length, and head circumference. Prior to each visit, you will enter information on formula intake, diaper changes and tolerance (e.g., gassiness, fussiness, and stool characteristics) into the study app on your smartphone. That’s It!
FAQs (Frequently Asked Questions)
If you still have questions, please check this FAQ and you may find the answers. If not, get in touch with us at email@example.com.
About Our Study
The goal of this study is to demonstrate that babies fed Bubs infant formula grow at the same rate as those fed a commercially available cow milk formula. Such a study is a requirement by the FDA to allow a new infant formula into the USA market. The study also includes a group of breastfed babies.
Bubs makes infant formula that is currently available for sale in the United States through the FDA Infant Formula Enforcement Discretion Policy due to the infant formula shortage. Per FDA guidance, Bubs is conducting this study to support its application to continue to market and sell its products in the United States.
Click Apply Now to complete the pre-screening questionnaire and see if you qualify to participate. If you and your baby qualify, you will receive an email confirming eligibility. The email contains instructions to schedule your first visit with the doctor to finalize enrollment.
This study is sponsored by Bubs Australia in partnership with Validcare, a leader in clinical scientific research. The study complies with the FDA and IRB regulations for clinical best practice. Our study is all about providing you and your baby the best experience and professional care. This study provides the best of a virtual trial for daily caregiver input, as well as the best of baby care with in-clinic visits. If you would like to learn more about our team, feel free to visit validcare.com. Feel free to contact us at firstname.lastname@example.org and we will be happy to answer your questions.
About Your Participation
The study takes up to 18 weeks, including enrollment and training. Once you have registered, you will be asked to occasionally visit a study doctor for growth measurements.. You will visit the doctor a total of 6 times over a 16 week period. You will enter the measurements and some additional information in the study app so we can track your baby’s formula consumption, tolerance, and growth.
The total compensation for completing the study is $300 spread out over six payments. Payments are made when study milestones are achieved by visiting the study doctor. If you are feeding your baby formula, you will receive the study product at no cost for the duration of the study as long as you visit the study doctor. If you successfully complete the study, you will receive a complimentary two-month supply of the study product. If you are breastfeeding your baby, you will receive an additional stipend at the study visits to help cover your diaper expenses.
Infants with a family history (parents or siblings) of confirmed milk or soy allergies cannot participate in this study. If your baby has a cow milk protein allergy or lactose intolerance, they are not eligible to join our study.
Yes! You can enroll in our study starting at your 35th week of pregnancy. You will be reminded about our study when your due date is getting closer.
Yes, you can. As our study also includes a group of babies that will be exclusively breastfed during the period of the study (16 weeks), please click Apply Now to check if you are eligible to join the breastfed group of our study. You will not be asked to use any formula or change your feeding plans in any way to participate in the study.
About the Infant Formula
Once you register for the study, you will meet with a study doctor to complete enrollment before your baby is 14 days old. At the end of the visit you will receive your assigned study formula. You will receive enough formula to make sure you have enough until your next visit. You will continue to receive your formula at the scheduled visits. So long as you continue to visit the study doctor, you will receive enough product. If you successfully complete the study, you will receive an additional two-month supply.
No, all formula-fed babies in the study have a 25% chance of one of the 3 Bubs study products or an infant formula currently in the US market. This is totally random, which is a requirement for the study, so that the interpretation of the growth measurements is not influenced by the research team knowingwhich formula your baby received. Selecting one formula over the other is not possible.
Yes, all study formulas meet the same strict FDA nutritional requirements as detailed in federal regulations, so you need not worry. We closely monitor your baby’s growth; however, this study does not replace your regular visits to your pediatrician.
If you think the formula does not agree with your baby, we recommend you contact our study team to discuss your concerns and our study doctor will get in touch with you. In medical emergencies you should contact your own physician.
About Bubs Australia
The sponsor of this study is Bubs Australia. Mom founded and led for nearly 20 years, Bubs’ purpose is to grow happy, healthy families through clean nutrition. Bubs provides high-quality natural milk sources, premium nutrition ingredients and secure local manufacturing. Bubs formulas provide families with gentle and clean nutrition to support the growth and development of their little ones.
Bubs takes pride in using the very best nature has to offer to create nutritious and high-quality food for all stages of a child’s development through the first 1,000 days of life. Bubs proudly offers clean label Australian made products with no additives commonly found in other formulas, giving parents peace of mind and babies a happy and healthy start to life.
Yes, the study and control formulas are currently available in the USA at local and national retailers and through ecommerce. Bubs formulas are currently in market through the FDA Infant Formula Enforcement Discretion Policy as a result of the infant formula shortage, and seek to remain long-term.
The Bubs product is made in Australia in its own state-of-the-art infant formula manufacturing facility registered with the US FDA.
Yes, it does. All infant formulas must meet the strict FDA nutritional requirements as specified by federal regulations, so you need not worry. This study is approved by the Institutional Review Board (IRB) and listed on clinicaltrials.gov.
Growing Generation Joy
Aussie Bubs, Inc.
1390 Market Street, Suite 200
San Francisco, CA 94102