Maternal and infant microbiome links to infant gut inflammation and pregnancy outcomes in people with IBD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• BC Children's Hospital Research Institute
  Vancouver, British Columbia, Canada Recruiting
• BC Children's Hospital Research Institute
  Vancouver, British Columbia, Canada Not yet recruiting

Study contacts

• Study coordinator: Genelle Lunken, PhD, RD
• Email: genelle.lunken@bcchr.ca
• Phone: 7782327016

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.