Last updated on December 2019

Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease

Brief description of study

Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications. Sometimes, concerns about transfer of drugs to infants via breast milk lead the mothers to either avoid breastfeeding or stop their medication.

Inflammatory Bowel Disease (IBD) is a chronic condition that is marked by an abnormal response of the body's immune system, and high levels of certain proteins that cause inflammation (Cytokines like Tumor Necrosis Factor-alpha or TNF). A group of drugs called "biologics" target and stop these proteins from causing inflammation, and have been successfully used to treat this condition. Inflammatory proteins may be present in breast milk of healthy women in variable levels, and may play a role in development of infant's brain and immune system.

This study is being conducted to investigate:

  • Concentration of some of the inflammatory proteins in breast milk of mothers with IBD and healthy controls
  • Interaction between these proteins and biologics in breast milk of women with IBD
  • Potential role of these proteins (and their interaction with biologics) on development of infant learning and memory function It has been presumed that concentrations of TNF and some other cytokines are higher in breast milk of women with IBD, and the biologics can normalize these high levels.

The study consists of four study visits: a) two home visits in the first 6 months postpartum to complete a questionnaire and collect a small sample of breast milk at each visit and b) two visits at the Hospital for Sick children for evaluation of learning and memory function of the infant at the ages of 12 and 18 months.

Detailed Study Description

The inflammatory bowel disease (IBD) shows the highest incidence among people of childbearing age. Indeed, it is not uncommon that pregnant or lactating women with IBD require drug therapy, including monoclonal antibodies against Tumor Necrosis Factor-alpha (TNF). However, these patients face challenges, because information on pregnancy and breastfeeding safety of these new medications is lacking due to exclusion of pregnant and breastfeeding women from drug development processes. Whereas the data necessary for fetal safety assessment is accumulating gradually, significant gaps in the research efforts and the understanding on excretion of TNF inhibitors into milk remain. Experts generally consider it acceptable to use the TNF inhibitors during breastfeeding, because the previous studies found relatively low levels of these drugs in milk. However, the existing data on milk levels of these drugs are highly inconsistent, probably because previous reports gave no consideration to potential interference from high levels of endogenous TNF in milk. As a result, a comprehensive picture of TNF inhibitors in breast milk remains obscure. Moreover, in a recent mouse study, transfer of TNF-dependent chemokines through milk has been shown to play a role in shaping the postnatal programming of brain development, implying that altered disposition of endogenous TNF and other chemokines in milk during anti-TNF therapy has an impact on brain development of the offspring.

This is an observational cohort study with comparison group, which describes the first step to address the issue by uncovering the TNF-dependent 'lactocrine' pathway and disposition of TNF inhibitors in milk. The study will also investigate the pharmacokinetics of TNF inhibitors in breast milk (as a sub-study), using the population pharmacokinetic (popPK) approach.

Clinical Study Identifier: NCT03397108

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Mount Sinai Hospital

Toronto, ON Canada
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The Hospital for Sick Children

Toronto, ON Canada
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