Have an inconsolable baby? Take part in a probiotic study aiming to ease crying and fussing symptoms in newborns with infantile colic. Participants will receive up to $200 and a month’s 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 symptom 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

Special note: While we understand all parents may take an active caretaking role, we do need the breastfeeding mother to facilitate study activities, sign consent forms, etc. as the primary caretaker.

Why participate in this study?

A chance to help your child

No parent wants to see their newborn in pain. By increasing the levels of ‘good’ bacteria in your baby’s gut, you may in turn see a decrease in your baby’s crying and fussing.

Help advance scientific research

Not only could your family be helped now, but this promising research could also help countless families with colicky babies 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 Obviohealth 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 probiotic can reduce the crying/fussing symptoms of colic in breastfed newborns. This study will also assess changes in baby’s daily sleep duration, mother’s sleep and well-being, and overall household quality of life.

What are probiotics?

Probiotics are beneficial bacteria consumed in supplements or found in store-bought foods, such as yogurt.

What is special about the probiotic used in this study?

 The probiotic used in this study is a bacteria called Bifidobacterium infantis, or B. infantis for short. 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 relieve symptoms associated with colic by establishing and maintaining a healthy gut composition.

What is a LENA device?

LENA stands for Language Environmental Analysis, and it is a small wearable device that can record your baby’s vocalizations for up to 24 hrs at a time. It is completely safe and uses a low-power processor similar to what powers hearing aids. A Windows PC will be required in order to upload your baby’s vocalizations into the LENA Hub for analysis.

Are there any risks involved in this study?

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

If my newborn isn’t medically diagnosed with infantile colic, can I still participate?

Yes. You do not need a doctor’s diagnosis and can simply fill out the screening questionnaire to find out if your newborn qualifies.

Is there compensation for my participation?

Yes! There is compensation available for your time and participation of up to $200 and a month’s supply of the commercially available study probiotic 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 monitoring their infant’s crying/fussing and collecting a sample of their infant’s stool. Primary requirements include having a diagnosis and/or symptoms of infantile colic, 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 (>3 days) where crying data and an infant stool sample is collected. Participants will then be randomly assigned to either the control group or the probiotic group. Participants will need to complete study tasks throughout the two-week supplementation period, and compensation will be given for time and participation after returning the LENA device.

What does my individual involvement entail?

Participation in this study includes monitoring your infant’s crying behavior with the LENA device, taking samples of their stool, filling out an in-app e-diary, and feeding your infant the study probiotic (to be mixed with breast milk).

How much time can I expect to put towards participation?

From baseline to finish, the total time is approximately 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.