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Exploring the Gut Microbiota and Dietary Contributors to Elevated Infant Fecal Calprotectin In Patients With Inflammatory Bowel Disease: A Pilot Study (CALINA-IBD)

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Healthy Volunteers: t
View:

⁃ 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.

Locations
Other Locations
Canada
BC Children's Hospital Research Institute
NOT_YET_RECRUITING
Vancouver
BC Children's Hospital Research Institute
RECRUITING
Vancouver
Contact Information
Primary
Genelle Lunken, PhD, RD
genelle.lunken@bcchr.ca
7782327016
Backup
Mathilde Wilhelmy
wilhelmy@student.ubc.ca
5813984638
Time Frame
Start Date: 2026-03-20
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: IBD Centre of BC, BC Children's Hospital Research Institute
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov