Actively Recruiting
Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease
Led by University of British Columbia · Updated on 2026-04-06
80
Participants Needed
2
Research Sites
97 weeks
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
B
BC Children's Hospital Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant individuals 19 years or older recruited during first, second, or early third trimester
- Ownership or regular access to a smartphone compatible with the RXFood app
- For IBD patients: Diagnosis of Crohn's disease or ulcerative colitis with active or quiescent disease
- For non-IBD controls: No diagnosis of IBD
You will not qualify if you...
- Unable to provide consent
- Previous gastrointestinal cancer or bowel surgery
- Renal disease
- HIV/AIDS or other serious infections
- Fetal chromosomal or structural abnormalities
- Other immune-mediated diseases such as multiple sclerosis, rheumatoid arthritis, or primary sclerosing cholangitis
- Use of prebiotic, probiotic, or postbiotic supplements within one month before first sample collection
- Gastroenteritis during or one month before first sample collection
- Travel outside Canada or the United States within one month before first sample collection
- For IBD patients: Pregnant individuals with active perianal or extra-intestinal disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada, V5Z 4H4
Not Yet Recruiting
2
BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada, V5Z 4H4
Actively Recruiting
Research Team
G
Genelle Lunken, PhD, RD
CONTACT
M
Mathilde Wilhelmy
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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