NCT07385807 Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease
| NCT ID | NCT07385807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | IBD (Inflammatory Bowel Disease) |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-03-20 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2026-03-20 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07385807 clinical trial?
This trial is open to female participants only, aged 19 Years or older, studying IBD (Inflammatory Bowel Disease). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07385807 currently recruiting?
Yes, NCT07385807 is actively recruiting participants. Contact the research team at genelle.lunken@bcchr.ca for enrollment information.
Where is the NCT07385807 trial being conducted?
This trial is being conducted at Vancouver, Canada, Vancouver, Canada.
Who is sponsoring the NCT07385807 clinical trial?
NCT07385807 is sponsored by University of British Columbia. The trial plans to enroll 80 participants.