Status:
COMPLETED
Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
MOUNT SINAI HOSPITAL
Crohn's and Colitis Foundation
Conditions:
Crohn's Disease
Ulcerative Colitis
Eligibility:
FEMALE
18+ years
Brief 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 ma...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Breastfeeding women with IBD or healthy breastfeeding women in the first 4-month postpartum period
Exclusion
- unable to communicate in English
- Present illness of chronic inflammatory conditions (except IBD)
- Mastitis
- Present acute or chronic infection
- use of a different anti-Tumor Necrosis Factor (TNF) drug within the last 2 months
Key Trial Info
Start Date :
August 31 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 5 2024
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03397108
Start Date
August 31 2017
End Date
November 5 2024
Last Update
March 4 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
2
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8