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

You can see all of the technical details of the study via clinicaltrials.gov.

Fill out the form below to register

Why participate in this study?

A chance to help your child

No parent wants to see their newborn in pain. The infant probiotics should ease the upset stomach and help to calm your newborn’s seemingly inconsolable crying.

Extra study perks

When participating in this study, participants are given a LENA device to closely monitor their baby’s vitals and crying data. Through this, parents are able to get to know their infant’s behavior better through technology and data collection.

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 the basic qualification assessment

Download the ClaimIt App

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

Participate

There will be a baseline period to collect data, and then participants will be randomized into the study arms.

How this works

Frequently Asked Questions

What is the purpose of this study?

The purpose of this study is to assess the effect of the probiotic, B. infantis EVC001, on reducing the crying/fussing symptoms of colic in breastfed newborns. Secondary objectives include increasing infant’s daily sleep duration, and mother’s quality of life.

What is B. infantis EVC001?

 The probiotic B. infantis EVC001 used in this study is a particular sub-species of Bifidobacterium that has historically been a large part of the breastfed infant gut microbiome and is currently missing from the gastrointestinal tract of most infants in the industrialized world. There is evidence to support that  B. infantis EVC001 supplementation may relieve symptoms associated with colic by establishing and maintaining the necessary 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 per charge. It is completely safe and uses a low-power processor similar to what powers hearing aids.

Are there any risks involved in this study?

No, there are no known potential risks associated with the probiotic, B. infantis EVC001 or the use of a LENA device.

What are the benefits of participating?

This probiotic is the only baby probiotic clinically proven to effectively restore B. infantis to a newborn’s get and reduce bad get bacteria by up to 80%. This could help increase infant comfort and in turn reduce familial stress.

If my newborn isn’t 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 30-day supply of the probiotic B. infantis EVC001 to be given 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 the infant’s crying/fussing and 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 (4-5 days) where crying and stool data is collected. Participants will then be randomized into either the control group or the probiotic group. At the end of the study another stool sample will be taken, and compensation will be given for time and participation.

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 material (to be mixed with breast milk).

How much time can I expect to put towards participation?

From baseline to finish, the total time is 3-4 weeks. Afterwards, you will be asked some questions for a few months to see how our child is doing. That can continue up to 10.5 months.

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.