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Study posting

Study title: Breastfeeding, IBD, and Infant Development
Principal investigator: Ito, Shinya
Study description: Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications during breastfeeding. Inflammatory Bowel Disease (IBD) is one of these chronic conditions that is associated with inflammation of the lining of digestive system and often affects women during their child bearing years. Sometimes, concerns about transfer of drugs through breast milk to the infants leads the mothers to either avoid breastfeeding or stop their medication. Like many other inflammatory conditions, IBD is associated with an abnormal function of immune system in our body, along with high levels of certain proteins that cause inflammation (like Tumour Necrosis Factor alpha or TNF alpha). New treatments called “biologics” that are made out of living sources (in contrast to most drugs that are chemically manufactured) can target and stop these proteins from causing inflammation. Biologics have been effectively used for treatment of many inflammatory conditions including IBD. Our knowledge about safety of biologics for infants during breastfeeding is limited. In order to learn more about safety of these treatments, it is important to measure their concentration in breast milk while keeping in mind their interaction with their target, TNF alpha. In fact, TNF alpha and similar proteins are also present variably in breast milk of healthy mothers and may play a role in development of infant’s brain and immune system. For this reason, it is important to learn more about TNF alpha concentration, as well as its relation with biologics in breast milk of women with IBD. We do this study to investigate concentration of some inflammatory proteins in breast milk, interaction between TNF alpha and biologics in breast milk of mothers with IBD, and potential role of TNF alpha and biologics in development of infant learning and memory function.
Recruitment information: We enroll two groups of participants in our study: 1- Pregnant, or lactating mothers with IBD in the first 2 months after childbirth 2- Healthy pregnant, or breastfeeding mothers in the 2 months after childbirth You may participate if you are over 18 years old, you are able to communicate in English, and live in the Greater Toronto Area. The study includes 2 home visits and 2 optional infant assessment visits, each lasting about one hour. Visit 1 and 2: During the home visits, between 2-6 weeks and 11- 16 weeks after childbirth, you will be asked to collect a breast milk sample (up to 10 ml or 2 teaspoonful) and fill out a questionnaire. A (female) research coordinator will drop off sample collection supplies at your doorstep and collect everything again at your doorstep following the rules of social distancing. Visit 3 and 4 (OPTIONAL): Your child will be examined at SickKids at the age of 12 and 18 months, for his/her cognitive function and language ability. You will receive your baby’s evaluation report, and a gift card in appreciation of your time and efforts. We will also reimburse your parking or transportation expenses to the hospital. If you decide not to do visit 3 and 4, we will ask you to report your baby’s communications and problem-solving abilities by completing a questionnaire at home at the ages of 12 and 18 months. Please contact the study coordinator if you are interested in participating in this research study.
Enrollment status: Closed enrollment closed Healthy volunteers healthy volunteers needed
Contact name: Pooja Dalvi
Telephone: 416-813-7654 ext205675
Website URL: