Bottle feeding your newborn?

Take part in a probiotic study aiming to restore your infant’s healthy gut microbiome. Participants will receive up to $__ and a 30-day supply of the study probiotic for their newborn. All study activities can be done from the privacy of your own home.

Trusted Researchers

Evolve Biosystems, is a microbiome company dedicated to researching and understanding the gut microbiome of infants and the role certain probiotics play in maintaining health and well-being.

Participate from home

Those participating can do all study related activities and monitoring from the comfort of their own home with virtual study team members available for any questions or concerns electronically or via phone.

study Details

This page will explain the details of the study and answer many of the questions you will have about it in the sections below. Click the “See More Details” button to jump to that section. You can also see all of the technical details of the study via (add study link here).

Fill out the form below to register

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Why participate in this study?

Get a bottle feeding starter kit

Formula is not cheap, when participating in this study you will be given formula to use during the course of the study, and a Baby Brezza to make prepping bottles easier for you and your infant. 

Extra study perks

By participating in this study, participants are not only given a Baby Brezza during the time of participation, but also to keep for themselves to use at their discretion afterwards. Participants will be given a 30 day supply of the commercially available formula, and will be compensated for their time.

Help advance scientific research

Not only could you set your family up for a successful bottle feeding experience while also helping gut health of your newborn, but this promising research could also help countless families with bottle feeding their newborns in the future. The more we know, the more we can do to help.

What will I have to do?

Fill out our form

Fill out the questionnaire above to see if your baby qualifies

Download the Obvio App

The app is where you will find study specifics and sign a consent form

Participate

There will be a baseline period in which you will asked to collect data about your baby in addition to a poop sample, and then participants will be assigned to a study group.

How this works

Frequently Asked Questions

What is the purpose of this study?

The purpose of this study is to determine whether a the specific probiotic that is lacking in the gut of newborn babies in the modern world, can be brought back to healthy, normal levels in bottle fed babies. Secondary objectives include reduction in potential pathogens, stool pH, and overall gut health.

What makes these probiotic supplements special?

 The probiotic used in this study is a sub-species within a family of ‘good’ bacteria called Bifidobacterium . This bacterium has historically been found in very high numbers in the gut microbiome of breastfed infants but is now missing from the gastrointestinal tract of most infants in the industrialized world. There is evidence to support that this probiotic supplementation may establishing and assist in maintaining a healthy gut composition.

What is a Baby Brezza?

Baby Brezza is a device that can prepare your baby’s formula quickly and easily. It is completely safe and is used in this study to make formula preparation easier for the mother.

Are there any risks involved in this study?

No, there are no known potential risks associated with the probiotic or the use of a Baby Brezza.

What are the benefits of participating?

This probiotic is the only baby probiotic clinically proven to effectively restore ‘good’ bacteria to a newborn’s gut and reduce bad gut bacteria by up to 80%. This could help increase infant comfort and regulate their gut microbiome.

If my newborn has been breastfed previously, can I still participate?

Yes. You need to just not have breastfed your infant within the 7 days leading up to consenting to participate, and exclusively bottle feed during the duration of the study.

Is there compensation for my participation?

Yes! There is compensation available for your time and participation of up to $XXX and a 30-day supply of the commercially available study probiotic at the end of the study along with the Baby Brezza. Payments will come in 3 parts: $50 after the baseline period, $100 after completing week 1, and $50 at the end of the study.

How do I know if I’m eligible?

Prospective participants will complete an eligibility screening and also a baseline survey with the study team to confirm full eligibility by collecting a sample of their infant’s stool. Primary requirements include exclusively bottle feeding your infant for the 7 days prior to consenting to participate, no recent antibiotic use by the mother, and no prior probiotic use for the infant.

How does the study work?

Participants will go through a baseline monitoring period (7 days) where an infant stool sample is collected. Participants will then be randomly assigned to either the control group or the probiotic group. At the end of the study another stool sample will be collected, and compensation will be given for time and participation.

What does my individual involvement entail?

Participation in this study includes taking samples of their stool, filling out an in-app e-diary, and feeding your infant the study material (to be mixed with formula).

How much time can I expect to put towards participation?

From baseline to finish, the total time is 3-4 weeks. 

Are there any direct costs to me while participating?

All costs related to the study are paid for by the sponsor.

Is my confidential health information protected?

The study doctor and some members of the study team will be able to see your health information and it will be used for the purpose of this study ONLY.

Is my participation voluntary and can I withdraw at any time?

Yes. Your decision to be a part of this study is entirely voluntary. You can decide to stop study treatment at any time during the study. If you wish to stop taking the supplement, please let the clinical study team know.

Please note: 1nHealth may store your data in a confidential and secure database. That personal information will never be shared or sold with any other persons or organizations not associated with 1nHealth. 1nHealth may/will use personal information to contact you directly by phone and/or email for matters related to potential participation in clinical trials for which the potential subject may qualify. See our Privacy Policy for more details.