Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease

NCT07385807 | Not Yet Recruiting

• 1 other identifier: CALINA-IBD
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IBD; IBD - Inflammatory Bowel Disease; Pregnancy

Keywords

Pregnancy; IBD; Crohn's Disease; Ulcerative Colitis; CALINA-IBD; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• 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, accounting for maternal adherence to Mediterranean diet.

  FCP, a marker of intestinal inflammation, will be quantified in maternal stool samples collected during the third trimester of pregnancy and the early postpartum period (2 weeks, 3 months, and 1 year postpartum), as well as in infant stool samples collected at 3 months and 1 year of age, using enzyme-linked immunosorbent assay (ELISA). Elevated infant FCP is defined as \>400 µg/g. Maternal gut microbiota composition and diversity will be characterized using long-read Oxford Nanopore 16S rRNA sequencing, and microbial metabolites will be quantified using gas chromatography-mass spectrometry (GC-MS). Maternal dietary intake during the third trimester and postpartum period will be assessed using 3-day dietary records completed via the RXFood mobile application. Adherence to the Mediterranean diet will be scored using the Mediterranean Diet Score (MDS; range 0-7), with scores of 4-7 indicating high Mediterranean diet adherence.

  24 months

Secondary Outcomes (4)

• Develop and validate a machine learning model for predicting elevated infant FCP levels at 1 year of age using maternal gut microbiota composition and dietary patterns as predictive features.

  24 months

• Characterize and compare HMO profiles between mothers with and without IBD, and determine their associations with the infant gut microbiota composition and the infant FCP levels at 3 months and 1 year of age.

  24 months

• Compare pregnancy outcomes between mothers with ulcerative colitis or Crohn's disease and those without IBD.

  24 months

• Correlation between maternal dietary patterns (macro and micronutrients) and maternal microbiota composition (gut, skin, and vaginal) and maternal and infant clinical outcomes, including pregnancy and postpartum complications.

  24 months

Study Arms (2)

Pregnant participants with Inflammatory Bowel Disease (IBD)

The study will include 40 consenting pregnant patients with IBD (Crohn's Disease (CD) or Ulcerative Colitis (UC)), varying in levels of severity depending on assigned SES-CD scoring (for CD patients) and Mayo score (for UC patients) from their gastroenterologist. Stool, vaginal swabs, and optional breastmilk samples and breast skin swabs will be collected using an at-home kit. The patient will receive all instructions and shipping materials in a kit delivered to their home.

Pregnant participants without Inflammatory Bowel Disease (IBD)

The study will include 40 consenting pregnant patients without a diagnosis of IBD. Stool, vaginal swabs, and optional breastmilk samples and breast skin swabs will be collected using an at-home kit. The patient will receive all instructions and shipping materials in a kit delivered to their home.

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators aim to have a total of 80 pregnant participants enrolled before week 35 of gestation. Patient grouping for recruitment is as follows:Group 1: 40 pregnant participants with a confirmed diagnosis of IBD, including either Crohn's Disease (CD) or Ulcerative Colitis (UC). Participants will have varying disease severity levels as determined by their gastroenterologist using standardized scoring systems: SES-CD (Simple Endoscopic Score for Crohn's Disease) for CD patients and Mayo score for UC patients.Group 2: 40 Control Pregnant individuals without a diagnosis of IBD, matched as controls for comparison.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• BC Children's Hospital Research Institute: collaborator
• IBD Centre of BC: collaborator

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Related Links

• Lunken Lab Website

Biospecimen

Retention: SAMPLES WITH DNA

Maternal vaginal swab, breastmilk, breast skin swab, and stool samples, as well as infant stool samples.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Genelle Lunken, PhD, RD

CONTACT

7782327016; genelle.lunken@bcchr.ca

Mathilde Wilhelmy

CONTACT

5813984638; wilhelmy@student.ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, BC Children's Hospital Registered Dietitian, IBD Centre of BC

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

CA (1)