Maternal and infant microbiome links to infant gut inflammation and pregnancy outcomes in people with IBD
Exploring the Gut Microbiota and Dietary Contributors to Elevated Infant Fecal Calprotectin In Patients With Inflammatory Bowel Disease: A Pilot Study (CALINA-IBD)
This project will see if mothers' microbiomes, diets, and breastmilk are linked to infant gut inflammation (measured by fecal calprotectin) in pregnant people with and without IBD.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | University of British Columbia Academic / other |
| Locations | 2 sites (Vancouver, British Columbia and 1 other locations) |
| Trial ID | NCT07385807 on ClinicalTrials.gov |
What this trial studies
This is a prospective longitudinal cohort that follows pregnant individuals with and without IBD and their infants through pregnancy and the first year of life. Participants provide serial fecal samples, one third-trimester vaginal swab, breastmilk, and dietary data via a smartphone app, and infants' fecal calprotectin (FCP) is measured as a marker of gut inflammation. The study compares microbiome compositions, human milk oligosaccharides (HMOs), and dietary patterns between IBD and non-IBD dyads and tracks associations with elevated infant FCP. Researchers will also attempt to build and validate a machine-learning model to predict high infant FCP at 1 year from maternal and infant microbiome and dietary data.
Who should consider this trial
Good fit: Pregnant individuals aged 19 or older in the first, second, or early third trimester, with or without a documented diagnosis of IBD, who can provide serial biological samples and use a compatible smartphone app for dietary tracking are ideal candidates.
Not a fit: People who are under 19, not pregnant, or who have exclusionary conditions such as prior gastrointestinal cancer or bowel surgery, major immune-mediated diseases, recent probiotic use, or serious infection are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could identify maternal or infant microbiome and dietary factors that point to dietary or breastfeeding interventions to reduce infant gut inflammation and potentially lower later risk of allergy or IBD.
How similar studies have performed: Prior observational research has linked maternal microbiota and infant fecal calprotectin to later allergic and IBD risk, but combining detailed microbiome, HMO profiling, dietary data, and machine-learning prediction in pregnancy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vancouver, British Columbia and 1 other locations
- BC Children's Hospital Research Institute — Vancouver, British Columbia, Canada (Not_yet_recruiting)
- BC Children's Hospital Research Institute — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Genelle Lunken, PhD, RD
- Email: genelle.lunken@bcchr.ca
- Phone: 7782327016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.