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

NCT03397108 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 79

Last updated 2025-03-04

Study results available
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Summary

Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications.

Inflammatory Bowel Disease (IBD) 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 observational study is 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.

Note: Due to the pandemic, the study now consists of reduced number of study visits. The mandatory visits include two home visits in the first 4 months postpartum to complete a participant questionnaire and collect a small sample of breast milk at each visit. The optional study visits consist of 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. Additionally, mothers will be required to complete for their infant subscales of The Ages and Stages Questionnaires®, Third Edition (ASQ®-3) either in person or over the telephone at the ages of 12 months and 18 months.

Conditions

Interventions

OTHER

The IBD group was divided into 2 subgroups: with or without anti-TNF antibody use

This observational study enrolled women with IBD, and some of them were receiving a treatment with anti-TNF monoclonal antibody, which was prescribed by their responsible prescribers at a standard dose and dosing interval.

Sponsors & Collaborators

  • MOUNT SINAI HOSPITAL

    collaborator OTHER

  • Crohn's and Colitis Foundation

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Shinya Ito, MD · The Hospital for Sick Children

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2022-11-30
Completion
2024-11-05

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03397108 on ClinicalTrials.gov