Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease
Observational · No treatment assigned · 2 sites · University of British Columbia
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: IBD (Inflammatory Bowel Disease), IBD and IBD - Inflammatory Bowel Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 19 and older
- Women only
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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.
Plus 3 more requirement(s). There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2026-03-20.
- Main results expected around 2028-02-01 (estimate from the record).
- 2 study sites listed (1 marked recruiting) in Canada.
Main thing being measured
- Correlation between maternal gut microbiota during pregnancy (third trimester) and early postpartum period (2 weeks, 3 months, and 1 year) and infant FCP levels at 3 months and 1 year of age,… (24 months)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | IBD (Inflammatory Bowel Disease); IBD; IBD - Inflammatory Bowel Disease; Pregnancy |
| Lead sponsor | University of British Columbia |
| Collaborators | BC Children's Hospital Research Institute; IBD Centre of BC |
| Enrollment | 80 (estimated) |
| Start date | 2026-03-20 |
| Primary completion (est.) | 2028-02-01 |
| First posted | 2026-02-04 |
| Last updated | 2026-04-06 |
| Official title | Exploring the Gut Microbiota and Dietary Contributors to Elevated Infant Fecal Calprotectin In Patients With Inflammatory Bowel Disease: A Pilot Study (CALINA-IBD) |
| ClinicalTrials.gov ID | NCT07385807 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| BC Children's Hospital Research Institute | Vancouver, British Columbia | Canada | Not yet recruiting |
| BC Children's Hospital Research Institute | Vancouver, British Columbia | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.