Actively Recruiting
Exploring the Gut Microbiota and Dietary Contributors to Elevated Infant Fecal Calprotectin in Patients With Inflammatory Bowel Disease: A Pilot Study
Led by University of British Columbia · Updated on 2026-04-06
80
Participants Needed
2
Research Sites
N/A
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
This research aims to understand how the microbiome of pregnant women, including bacteria and fungi in the gut, vaginal canal, skin, and breastmilk, may affect inflammation in their infants' intestines. The study focuses on pregnant individuals with and without inflammatory bowel disease (IBD) and explores how maternal gut microbiota and diet relate to infant gut inflammation, measured by fecal calprotectin (FCP) levels. Researchers will also investigate breastmilk components and use a machine learning model to predict infant gut inflammation based on microbiota and diet data. The study involves two groups of pregnant participants: 40 with IBD (Crohn's disease or ulcerative colitis) and 40 without IBD. Participants will provide stool samples, vaginal swabs during the third trimester, and optional breastmilk and breast skin swabs using at-home kits. They will complete 3-day diet recalls via a smartphone app at four key timepoints: around week 34-35 of pregnancy, 2 weeks postpartum, 3 months postpartum, and 1 year postpartum. This allows comparison of microbiome and dietary factors during pregnancy and after birth. Participants will be followed for 12 months after birth, during which maternal and infant stool samples will be analyzed for microbiota composition and FCP levels. Dietary patterns and breastmilk components will also be monitored. Outcomes will include associations between maternal microbiome and infant inflammation, development of a prediction model for infant FCP levels, and examination of pregnancy and infant health outcomes. The study will help identify factors that could guide dietary interventions to improve infant health in families affected by IBD.
CONDITIONS
Brief 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 aged 19 years or older in their first, second, or early third trimester
- Own or have regular access to a smartphone compatible with the study app
- For IBD patients: documented diagnosis of Crohn's disease or ulcerative colitis with active or quiescent disease
- For non-IBD controls: absence of inflammatory bowel disease
You will not qualify if you...
- Inability to provide consent
- History of gastrointestinal cancer or bowel surgery
- Renal disease
- HIV/AIDS or other serious infections
- Fetal chromosomal or structural abnormalities
- Other immune-mediated diseases like multiple sclerosis, rheumatoid arthritis, or primary sclerosing cholangitis
- Use of prebiotic, probiotic, or postbiotic supplements within one month prior to first sample collection
- Gastroenteritis during or one month before the first sample collection
- Travel outside Canada or the United States within one month prior to first sample collection
- For IBD patients: active perianal or extra-intestinal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - From 3rd trimester (week 34-35) through 1 year postpartum
Participants provide stool, vaginal swabs, and optional breastmilk and breast skin swabs using at-home kits. Dietary recalls and clinical data are collected to assess maternal and infant microbiota and health.
4 at-home sample collection timepoints: 3rd trimester, 2 weeks postpartum, 3 months postpartum, and 1 year postpartum
Duration - Up to 1 year postpartum
Participants are observed over time to track infant fecal calprotectin levels, maternal diet, microbiota changes, and infant health outcomes up to 1 year postpartum.
Ongoing remote data collection aligned with sample collection timepoints
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
M
Mathilde Wilhelmy
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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