HUMAN MILK STUDIES

We’re currently enrolling lactating individuals into the following studies:

Motegrity® (prucalopride)
Our team is examining whether Motegrity® (prucalopride), a medication taken for the treatment of functional constipation in adults, can be found in human milk. We’re looking for lactating individuals who are currently taking Motegrity®. Participation in this research study includes phone interviews, self-collection of human milk samples at different time points over a 24-hour period before and after taking a dose, questionnaires about baby’s growth and development, and releasing baby’s medical records. Volunteers receive up to $125 for completing the study. See if you qualify.

PTN CUDDLE Study: Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
It is common for new mothers to have symptoms or medical conditions that must be treated with drugs. The CUDDLE study aims to identify safe dosing levels of common medications for both mom and the breastfed baby by tracking the transfer of the medication through human milk. Our study is enrolling persons with babies under 6 months who are currently taking a medication of interest as part of their routine care. Participants must be located in San Diego area for a one hour in-clinic visit.  Below is the current list of medications of interest:   

Amoxicillin
Buprenorphine
Bupropion
Cyclobenzaprine
Duloxetine
Gabapentin
Hydrocodone
Levetiracetam
Paroxetine
Trazadone
Venlafaxine

 Learn more by contacting our research team. 

What Is Colostrum?

A baby’s first meals may help them improve immunity, fight germs, and promote gut health. Colostrum is the first form of breastmilk that is released by the mammary glands after giving birth. It’s nutrient-dense and high in antibodies and antioxidants to build a newborn baby’s immune system. It changes to breast milk within two to four days after your baby is born. Human infants have a relatively long period of colostrum feeding (48-72 hours), suggesting the importance of this “liqud gold” in infant development. However, nearly 20% of infants are fed formula within the first 2 days of birth, potentially depriving them of critical factors in colostrum needed for long-term health. Breast milk is recommended as the sole source of nutrition for infants to 6 months of age. However, only 25% of infants in the US meet this goal. Participants are now enrolling into this study looking at colostrom and the key properties needed for optimal newborn nutrition. As part of this study, we will ask you to provide a sample of your milk and cheek swab within one or two days after giving birth and then again a few weeks later. These samples will be used to examine the characteristics of early breast milk. All samples are collected by the mom remotely and then mailed to the study office. Participants will receive a $50 gift card to compensate them for their time. See if you qualify.

This following study is no longer enrolling:

Diversity of Human Milk & How It May Be Affected by Maternal Use of Antibiotics
Our team is examining the diversity of human milk by enrolling 480 nursing parents and their nursing infant who is less than 6 months old. Participation in this study includes phone interviews, self-collection of milk samples, self-collection of stool samples and skin swab samples from both the nursing parent and baby, self-collected samples from certain areas of the home, questionnaires about baby’s development, release of medical records, and weekly text messages inquiring about use of any prescription antibiotics and/or changes in nursing. Enrollment is open to persons residing in Southern California. 

From the responses to the weekly text messages, our second goal is to identify 40 nursing parents who are prescribed an antibiotic while they are still lactating, and to enroll them in additional follow-up activities. We will also identify and enroll two comparison groups: 20 parents who are prescribed an antibiotic but are no longer lactating, and 40 lactating parents/babies without antibiotic exposure. For all three of these groups, additional samples will be collected from the parent, the baby, and their home. The goal is to learn whether and/or how prescribed antibiotics that are taken by a lactating parent affects human milk, and whether they have any effect on a baby’s growth and development.

Donate a Milk Sample to the Human Milk Biorepository 

Mommy’s Milk Human Milk Research Biorepository at UC San Diego is building a research database that will be used to evaluate human milk. As the first-ever human milk research biorepository in the nation, we are moving science forward through highly-trained researchers contributing to human milk breakthroughs and discoveries.

Since 2014, we have been collecting human milk samples and de-identified clinical data from lactating individuals across the U.S. These samples and data can be accessed by researchers to answer critical questions about human milk and its effects on infant and child health. Our biorepository depends on lactating parents providing a milk sample for future research projects. Did you know, one ounce of human milk can fuel 15 research studies!

Details About Our Research

Learn more about how you can get involved and request human milk samples for your research project.

Clinical data points that are collected include:

  • Maternal Age
  • Race
  • Ethnicity
  • Education
  • Income
  • Primary Language
  • Height
  • Weight
  • Pregnancy History (Gravidity, Parity, SAB,TAB)
  • Lactating History (Lactating History and Duration)
  • Child Eating Habits (EBF, Formula, Solids)
  • Personal Medical History
  • Family Medical History
  • Child Age
  • Child Birth Weight, Length and Head Circumference
  • Child Apgar Scores
  • Preterm Birth
  • Delivery Mode
  • Child Current Weight, Length and Head Circumference (at the time of the milk sample)
  • Pediatric abnormalities
  • Maternal exposures (dose, frequency, dates for 7 days prior to collection)
  • Adverse Reactions
  • Maternal sleep habits
  • Maternal exercise habits
  • Milk sample collection conditions
  • EPDS score
  • STAI score
  • PSS-10 score
  • Food Frequency Questionnaire
  • ASQ
  • CDI
  • ITSEA
  • MCHAT

Sample Processing and Storage: Upon receipt, milk samples are aliquoted and transferred to the Altman Clinical and Translation Research Institute (ACTRI) Biorepository, where they are stored in -80 degree conditions. The ACTRI Biorepository was supported by the National Institutes of Health, Grant UL1TR000100 of CTSA funding prior to August 13, 2015 and is currently supported by Grant UL1TR001442 of CTSA funding beginning August 13, 2015 and beyond. For more information, visit the ACTRI Biorepository.