Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease
Recruiting · NCT07385807 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of British Columbia
View the official record on ClinicalTrials.gov →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.
Who can take part
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 it is running
4 locations listed.
- BC Children's Hospital Research Institute - Vancouver, British Columbia, Canada
- BC Children's Hospital Research Institute - Vancouver, British Columbia, Canada
- BC Children's Hospital Research Institute - Vancouver, British Columbia, Canada
- BC Children's Hospital Research Institute - Vancouver, British Columbia, Canada