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
Sex
FEMALE
Min age
19 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
All patients
* 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.
IBD patients
● A documented IBD diagnosis (CD or UC) with active or quiescent disease.
Non-IBD controls ● Absence of IBD.
Exclusion Criteria:
All patients
* Inability to provide consent
* Previous gastrointestinal cancer or bowel surgery
* Renal disease
* HIV/AIDS or other serious infection
* Fetal chromosomal or structural abnormalities
* Other immune-mediated diseases (e.g., multiple sclerosis, rheumatoid arthritis, primary sclerosing cholangitis)
* Prebiotic, probiotic or postbiotic supplements in the month prior to first sample collection
* Gastroenteritis during or 1 month before the first sample collection
* Travel outside of Canada and the United States in the month prior to first sample collection
IBD patients
● Pregnant individuals with active perianal or extra-intestinal disease in IBD
Primary outcome measure(s)
Correlation between maternal gut microbiota during pregnancy (third trimester) and early postpartum period (2 weeks, 3 months, and 1 year) and infant FCP levels at 3 months and 1 year of age, accounting for maternal adherence to Mediterranean diet. — 24 months FCP, a marker of intestinal inflammation, will be quantified in maternal stool samples collected during the third trimester of pregnancy and the early postpartum period (2 weeks, 3 months, and 1 year postpartum), as well as in infant stool samples collected at 3 months and 1 year of age, using enzyme-linked immunosorbent assay (ELISA). Elevated infant FCP is defined as \>400 µg/g. Maternal gut microbiota composition and diversity will be characterized using long-read Oxford Nanopore 16S rRNA sequencing, and microbial metabolites will be quantified using gas chromatography-mass spectrometry (GC-MS).
Maternal dietary intake during the third trimester and postpartum period will be assessed using 3-day dietary records completed via the RXFood mobile application. Adherence to the Mediterranean diet will be scored using the Mediterranean Diet Score (MDS; range 0-7), with scores of 4-7 indicating high Mediterranean diet adherence.
Trial sites (2)
Facility
City
Region
Status
BC Children's Hospital Research Institute
Vancouver
British Columbia
Not Yet Recruiting
BC Children's Hospital Research Institute
Vancouver
British Columbia
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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