Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease

The goal of this prospective longitudinal cohort study is to examine how the human microbiome of pregnant women-including bacteria and fungi in the gastrointestinal tract, vaginal canal, skin, and breastmilk-may influence infant gut inflammation, measured by fecal calprotectin (FCP) levels, and to identify factors that could inform dietary interventions to improve infant health outcomes. Specifically, the study aims to determine which maternal gut microbiome characteristics and dietary patterns during pregnancy are associated with elevated FCP levels in infants, and which infant gut microbiota compositions and dietary factors are linked to high FCP levels. Researchers will compare microbiome signatures and dietary factors in pregnant women and their infants with active or inactive IBD, as well as non-IBD controls, to identify microbial patterns that may predict infant gut inflammation. Participants will provide fecal samples at all study timepoints, one vaginal swab during the third trimester of pregnancy, and optional breastmilk and breast skin swab samples. They will also complete 3-day diet recalls using a smartphone app and participate in a longitudinal follow-up over 12 months after birth to monitor dietary patterns, microbiome profiles, and gut inflammation in both mother and infant.

NCT Number	NCT07385807
Lead Sponsor	University of British Columbia Collaborators: BC Children's Hospital Research Institute, IBD Centre of BC
Conditions	IBD (Inflammatory Bowel Disease), IBD, IBD - Inflammatory Bowel Disease, Pregnancy
Enrollment	80 participants
Start Date	2026-03-20
Primary Completion	2028-02-01 (estimated)
Study Completion	2028-02-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-06