Recruiting soon

CALINA-IBDMaternal Gut Microbiota, Diet, and Infant Fecal Calprotectin Levels in Inflammatory Bowel Disease

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This observational study aims to explore the connection between a mother's gut microbiota during her third trimester of pregnancy and early postpartum period, her adherence to a Mediterranean diet, and her infant's fecal calprotectin levels at 3 months and 1 year of age, which is a marker for intestinal inflammation.

What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Colitis+6

+ Colitis, Ulcerative

+ Colonic Diseases

Over 19 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2026
See protocol details

Summary

Principal SponsorUniversity of British Columbia
Study ContactGenelle Lunken, PhD, RDMore contacts
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on Inflammatory Bowel Disease (IBD), a condition that often affects people during their reproductive years. About 25% of IBD patients have children after their diagnosis. The study aims to understand how the mother's gut microbiome, diet, and breastmilk composition might influence the infant's health. Specifically, it looks at a marker of gastrointestinal inflammation called fecal calprotectin (FCP). High FCP levels in infants can lead to increased risks of asthma, eczema, and IBD later in life. The study hopes to identify factors that could guide dietary interventions to improve infant health outcomes. During the study, changes in microbiota and dietary habits will be evaluated in mothers with IBD and without IBD, both during and after pregnancy. Data and samples will be collected at four different times: during the 3rd trimester, 2 weeks after birth, 3 months after birth, and 1 year after birth. These samples include stool samples from both mother and infant, breastmilk, and vaginal swabs. The primary outcome is to determine the association between the mother's gut microbiota during the third trimester and early postpartum period, and the infant's FCP levels at 3 months and 1 year. This association will be studied while also considering the mother's adherence to a Mediterranean diet.

Official TitleExploring the Gut Microbiota and Dietary Contributors to Elevated Infant Fecal Calprotectin In Patients With Inflammatory Bowel Disease: A Pilot Study (CALINA-IBD)
Principal SponsorUniversity of British Columbia
Study ContactGenelle Lunken, PhD, RDMore contacts
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ColitisColitis, UlcerativeColonic DiseasesCrohn DiseaseDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

4 inclusion criteria required to participate
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.

Absence of IBD.

A documented IBD diagnosis (CD or UC) with active or quiescent disease.

10 exclusion criteria prevent from participating
Pregnant individuals with active perianal or extra-intestinal disease in IBD

Inability to provide consent

Previous gastrointestinal cancer or bowel surgery

Renal disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

BC Children's Hospital Research Institute

Vancouver, CanadaOpen BC Children's Hospital Research Institute in Google Maps
Recruiting soonOne Study Center