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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19+
SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

Qualifiers

Pregnant individuals ≥19 years recruited during their first, second or early third trimester.

Own or have regular access to a smartphone compatible with the study smartphone application RXFood.

Disqualifiers

Inability to provide consent

Previous gastrointestinal cancer or bowel surgery

Renal disease

HIV/AIDS or other serious infection

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

80 Participants
are grouped into 2 trial groups

Sponsors and collaborators

University of British Columbia

Lead sponsor

BC Children's Hospital Research Institute

Collaborator

IBD Centre of BC

Collaborator