Recruiting

Microbiome & Diet

Sponsor:

University of British Columbia

Code:

NCT07385807

Conditions

IBD (Inflammatory Bowel Disease)

IBD

IBD - Inflammatory Bowel Disease

Pregnancy

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Accepted

Study Details

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 (Inflammatory Bowel Disease)

IBD

IBD - Inflammatory Bowel Disease

Pregnancy

Study ID

NCT07385807

Start date

Mar 20, 2026

Status verified date

Mar, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • 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. [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Locations

BC Children's Hospital Research Institute

Recruiting

Vancouver, British Columbia, Canada, V5Z 4H4

Contacts

More Information

Sponsor

University of British Columbia

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-04-06.