NCT07385807Recruiting
Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease
Exploring the Gut Microbiota and Dietary Contributors to Elevated Infant Fecal Calprotectin In Patients With Inflammatory Bowel Disease: A Pilot Study (CALINA-IBD)
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 26 Jan 2026
- Start date
- 20 Mar 2026
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- University of British Columbia
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07385807
What you commit to
- Study type: Observational
- Planned participants: 80
- From 20 Mar 2026 to the primary completion date, 1 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gastrointestinal cancer or bowel surgery
- 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
Other illness
- Renal disease
- HIV/AIDS or other serious infection
- Other immune-mediated diseases (e.g., multiple sclerosis, rheumatoid arthritis, primary sclerosing cholangitis)
Other
- All patients
- Inability to provide consent
- Fetal chromosomal or structural abnormalities
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BC Children's Hospital Research Institute Coordinator of this site? Confirm its status | Vancouver | Canada | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.