Omvoh Study
A study to measure mirikizumab levels in breast milk of lactating participants receiving mirikizumab therapeutically for an approved infection.
- Sex: Female
- Age: Adult (18 - 64)
- Accepting Healthy People: No
- Type: Observational
- Trial Phase: Phase IV
- Conditions Being Studied: Crohns Disease, Inflammatory Bowel Disease (IBD), Ulcerative Colitis
Study Purpose
This study is being done to understand the amount of mirikizumab in breast milk at different times and how it changes over time. The study also aims to monitor the weight of breastfed infants and collect information about any side effects experienced by the infants as reported by their caregiver or healthcare providers.
Who Can Participate
Assigned female at birth over 19 with an infant who are at least 36 weeks gestational age at birth Lactation history is well established, with the mother exclusively breastfeeding her infant (not to exceed more than 1 bottle of formula per day) Mother participant is receiving treatment with mirikizumab as prescribed by her doctor Participant must not be pregnant
Locations
UH Cleveland Medical Center
11100 Euclid Ave
Cleveland OH, 44106
UH Landerbrook Health Center
5850 Landerbrook Dr
Mayfield Heights OH, 44124
- UH IRB: SITE00002654
- StudyID: 2026-01841
- ClinicalTrials.gov: N/A
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