Who is conducting this Study?
The REMEDI Study is led by Dr. Jennifer Smilowitz, PhD, at the UC Davis Foods for Health Institute in collaboration with Dr. Mark Underwood MD, at the UC Davis Medical Center. This study has been reviewed and approved by the UC Davis Institutional Review Board. This study is funded by Evolve BioSystems Inc., a probiotic company (https://www.evolvebiosystems.com/).
The purpose of this 9-week study is to determine if a probiotic supplement given for 28 days to 2 to 4 month old breastfed or breast milk fed (in a bottle) infants, increases levels of beneficial bacteria in their stool. We will compare the effect of feeding a high, medium, or low dose of the probiotic supplement against a placebo-control supplement on changes in infant fecal bacteria.
Who can participate?
- Healthy mothers who are 21-45 years old and gave birth to a single, healthy, term (>37 weeks) infant;
- Exclusively breastfed infants who are 2 to 4 months old;
- Mothers who plan to continue to exclusively breastfeed their infants until at least 6 months of age;
- Participants who live within 20 miles from Davis or Sacramento;
- Healthy infants without medical complications.
Who is NOT eligible to participate?
- Infants who have consumed infant formula on more than 10 days;
- Infants who have consumed probiotics in the past 4 weeks;
- Infants who have taken antibiotics in the past 4 weeks;
- Infants who have consumed iron supplements in the past 4 weeks;
- Infants who have a medical or nutritional need for iron supplements;
- Mothers who smoke or plan to start smoking during the study period;
- Mothers with obesity (BMI > 35.9).
What is expected of me during the study?
This study lasts up to 2 months. Over the study period you will be asked to do the following: continue to exclusively breastfeed your baby; feed your baby the study supplement for 28 days; collect 3 breast milk samples from you and 3 urine and 8 stool samples from your baby’s diaper. Study personnel will instruct you on how to feed the study supplement to your baby and how to collect samples. You will be asked to store the collected samples in your freezer until scheduled campus visits. You will be asked to fill out daily and weekly questionnaires regarding your baby’s health, diet and environment. You will be asked to come to the UC Davis Robert Mondavi Institute in Davis, CA on 4 different occasions.
Will I be compensated for participation?
Participants may receive up to $200 in gift cards. After completing the 2 month study, participants will be offered a complimentary 28-day course of the medium dose of the probiotic that is commercially available (www.evivo.com).
For more information please contact the Human Studies Coordinator, (888) 217-5355 or email at: firstname.lastname@example.org.
Visit the Study Website: https://remedi.ucdavis.edu/