Zinnia Lactation Study

What is a lactation study?

A lactation study collects health information and samples from individuals who take prescription medicines while breastfeeding. Sometimes, information and samples are also collected from the breastfed infant.

Who is eligible to participate?

Patients may be eligible if they are:

  • A resident of the United States
  • A breastfeeding individual aged 18 years or older diagnosed with either multiple sclerosis or ulcerative colitis who:
    • Is taking (or planning to take) Zeposia® (ozanimod) while breastfeeding
    • Is not currently pregnant or planning to become pregnant during the study
    • Is at least two weeks postpartum and has been breastfeeding/pumping for at least two weeks.
    • Is willing to breastfeed or pump regularly during the study to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection during the second study visit
    • Is planning to provide milk (pumped or direct breastfeeding) to infant at least 2 times per day from study visit 1 until study visit 2.
    • Has delivered a term infant less than 12 months ago that had a normal weight at time of birth, and currently has a normal weight

How do I enroll a patient?

If you have patients who you think may be eligible, you can help them enroll by having them:

Complete the Potential Participant Contact Request Form here and a Study Team member will contact them.

Call the study team voice mailbox toll-free at
877-223-3576 followed by the World Reach Number code of 51003. You can call and leave contact information any time of the day or night. Calls will be returned during business hours 8:30 AM-5:30 PM EST Monday- Friday.

Why is this study needed?

Multiple sclerosis and ulcerative colitis are both conditions affecting reproductive aged individuals. Since breastfeeding individuals are typically excluded from clinical trial participation, there is limited data on the pharmacokinetics of medications in breastmilk and limited safety data for the potential impact of exposure for the breastfed infant.

Screening Visit (Visit 1)

At the screening visit information and samples (blood, urine) will be collected from the patient to assess whether they meet the inclusion and exclusion criteria to participate in the study. The patient will also undergo a physical examination, have vital signs collected, and will undergo a 12-lead ECG if one has not been performed within the 6 months prior to enrollment in the study.

The infant will also undergo a physical exam and a blood sample will be collected via heel stick.

Study Visit 2

If the patient is deemed eligible to participate based on the Screening Visit, they will have a second study visit approximately 3 months after the first visit.

At this time, the patient will undergo a second shorter physical exam and information will be collected as to whether there have been any changes in medications/procedures or any adverse events for the patient or the infant.

Blood, urine, and breast milk samples will be collected from the patient and a second heel-stick blood sample will be collected from the infant.

Finally, a safety follow-up call will take place approximately 30-40 days after the second study visit.

There will be no changes to the patients’ medications or clinical care.

Eligible patients will receive compensation for providing information and samples to the study.

The lactating individual will be asked to provide information at the Screening Visit, Visit 2, and during the safety follow-up call.

The following data will be collected:

  • Maternal height and weight
  • Maternal medical, obstetrical, and postpartum history
  • Maternal prior and current medications/procedures
  • Infant medical history
  • Infant prior and current medications/procedures
  • Infant weight
  • Maternal and/or Infant Adverse Events

Thank you for your support in recruiting potential participants.