Gut bacteria, diet and infant gut inflammation in mothers with inflammatory bowel disease
Follows pregnant women with inflammatory bowel disease and their infants, studying gut bacteria and diet.
Plain-language title generated from the registry record
Registry title: Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease
Key facts
- Where
- Vancouver, CanadaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for pregnant women aged 19 or older, some with inflammatory bowel disease (Crohn's disease or ulcerative colitis) and some without. They are followed through pregnancy and 12 months after birth.
- Age
- 19 years and older
- Sex
- Women (pregnant individuals)
- Disease stage
- Pregnant in the first, second or early third trimester. One group has Crohn's disease or ulcerative colitis, active or quiet. The other group has no IBD.
- Earlier treatment
- No prebiotic, probiotic or postbiotic supplements in the month before the first sample.
Main reasons for not taking part
- Cannot give consent
- Earlier gastrointestinal cancer or bowel surgery
- Kidney disease
- HIV/AIDS or another serious infection
- Other immune-mediated diseases, such as multiple sclerosis or rheumatoid arthritis
This trial only enrols pregnant participants. The registry sentence this rests on: Pregnant individuals ≥19 years recruited during their first, second or early third trimester.
Read by machine on 9 November 2026.
Where in Canada
- BC Children's Hospital Research InstituteVancouver, CanadaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of British Columbia
- Trial code
- NCT07385807
- Record updated
- 6 April 2026
- Original description
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.Read full original descriptionShow less
Exploring the Gut Microbiota and Dietary Contributors to Elevated Infant Fecal Calprotectin In Patients With Inflammatory Bowel Disease: A Pilot Study (CALINA-IBD)
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.
Inclusion: 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: 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; Renal disease; HIV/AIDS or other serious infection; Other immune-mediated diseases (e.g., multiple sclerosis, rheumatoid arthritis, primary sclerosing cholangitis); All patients; Inability to provide consent; Fetal chromosomal or structural abnormalities.