IBD (Inflammatory Bowel Disease)CALINA-IBDNCT07385807
Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease
An observational study of IBD (Inflammatory Bowel Disease) and IBD, run by University of British Columbia at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- IBD (Inflammatory Bowel Disease), IBD, IBD - Inflammatory Bowel Disease
- How many people
- 80 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Mar 2026to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z 4H4
Research Assistant, 6042835235 ext. 202, calina.ibd@ubc.ca
- Recruiting
BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z 4H4
Mathilde Wilhelmy, 5813984638, wilhelmy@student.ubc.ca
About this study
Official title: 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.
Read the detailed description
Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition that often presents during reproductive years, with approximately 25% of IBD patients having children after diagnosis. IBD during pregnancy can negatively impact infant health, as infants born to parents with IBD frequently exhibit higher fecal calprotectin (FCP) levels, a marker of gastrointestinal inflammation. Elevated FCP levels have been associated with increased risks of asthma, eczema, and IBD later in life. The purpose of this study is to examine how the maternal gut microbiome, diet, and breastmilk composition influence infant FCP levels and to identify factors that may guide dietary interventions to improve infant health outcomes. Specifically, the study aims to: (1) identify pregnancy-related maternal gut microbiota and dietary factors linked to elevated infant FCP levels, (2) determine infant gut microbiota and dietary factors associated with high FCP levels, (3) validate a supervised machine learning model capable of predicting high FCP levels in infants at 1 year of age using microbiota and dietary data, and (4) characterize human milk oligosaccharide (HMO) composition in breastmilk of mothers with and without IBD and its association with infant gut microbiota and FCP levels. This prospective study will evaluate changes in microbiota and dietary habits during and after pregnancy among maternal IBD patients (with active or quiescent disease) and non-IBD controls and their infants. Participants will be recruited during pregnancy (1st, 2nd, and early 3rd trimesters), and data and samples will be collected at four timepoints: 3rd trimester (week 34-35), 2 weeks postpartum, 3 months postpartum, and 1 year postpartum. Collected data will include 3-day dietary recalls, maternal and infant stool samples (for microbiota composition and FCP levels), optional breastmilk and breast skin swabs, vaginal swabs, and pregnancy and infant outcomes. These data will be integrated into a machine learning model to predict high infant FCP levels at 1 year, considering known covariates and factors identified in this study. The primary outcome is to determine the association between maternal gut microbiota composition-specifically the abundance of anti-inflammatory bacteria such as Faecalibacterium and Bifidobacterium-during the third trimester and early postpartum period, and infant FCP levels at 3 months and 1 year, accounting for maternal adherence to Mediterranean dietary patterns. Secondary outcomes include developing and validating a machine learning model for predicting elevated infant FCP at 1 year, characterizing and comparing HMO profiles between IBD and non-IBD mothers and their associations with infant gut microbiota and FCP levels, comparing pregnancy outcomes between mothers with ulcerative colitis, Crohn's disease, and non-IBD controls-including the impact of IBD therapy and mode of delivery-and examining the associations between maternal diet, microbiota composition (gut, skin, and vaginal), and pregnancy and infant outcomes across all study timepoints.
- Keywords
- Pregnancy, IBD, Crohn's Disease, Ulcerative Colitis, CALINA-IBD, Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
This multi-modal integrative supervised machine learning (sPLS-DA33; http://mixomics.org/) will integrate infant and pregnancy gut microbiota and dietary features to predict elevated infant FCP levels at 1 year. These features will be used to train predictive models with Random Forest Classifier and Artificial neural networks (ANN) providing complementary approaches for robust prediction. Cross-validation (20 × 5-fold) will optimize model performance and generalizability.
Measured: 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.
Human milk oligosaccharide (HMO) composition will be characterized and compared between mothers with IBD and healthy controls using breastmilk samples collected postpartum. Participants will be asked to perform a full breast expression (~5-10 mL) and the breastmilk will be alliquot and stored at -80 degrees freezer. Breastmilk composition, specifically HMO, will be analyzed using ultra-performance liquid chromatography with fluorescence (UPLC-FL) in Dr. Lars Bode laboratory from the University of California San Diego. The study will identify specific HMO profiles and assess their associations with infant gut microbiota composition and fecal calprotectin (FCP) levels at 3 months and 1 year of age. This analysis will help determine whether maternal IBD status could influence HMO composition and whether specific HMO profiles impact infant gut health and inflammation markers, potentially informing nutritional strategies to support optimal infant gastrointestinal development.
Measured: 24 months
Compare pregnancy outcomes between mothers with ulcerative colitis or Crohn's disease and those without IBD.
Pregnancy outcomes will be collected via chart review, and via a questionnaire completed by the participant to gather data on health outcomes. This study will compare pregnancy outcomes between mothers with ulcerative colitis (UC) or Crohn's disease (CD) and those without IBD. The analysis will examine the impact of IBD therapies, including steroids and advanced biologics, on maternal and infant health outcomes. Additionally, the study will investigate the relationship between mode of delivery (vaginal versus cesarean section) and outcomes for both mothers and infants. This comparison will provide insights into how IBD disease management and delivery methods influence pregnancy-related health outcomes, contributing to evidence-based care recommendations for pregnant individuals with IBD.
Measured: 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.
Maternal dietary patterns will be assessed using 3-day food diaries collected via RxFood, an AI-enabled dietary assessment application. Maternal microbiota composition (gut, breast skin, and vaginal) will be analyzed in relation to pregnancy and postpartum complications assessed during the third trimester and at 2 weeks, 3 months, and 1 year postpartum. Infant clinical outcomes will be assessed at birth, 2 weeks, 3 months, and 1 year of age using participant-completed questionnaires and review of relevant medical records.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start20 Mar 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- BC Children's Hospital Research Institute, IBD Centre of BC
- Responsible party
- Principal investigator, Genelle Lunken, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385807
- Sponsor's protocol ID
- CALINA-IBD
- Acronym
- CALINA-IBD
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Gut Microbiota and Dietary Contributors to Elevated Infant Fecal Calprotectin In Patients With Inflammatory Bowel Disease: A Pilot Study (CALINA-IBD)
- ClinicalTrials.gov ID
- NCT07385807
- Acronym / sponsor ID
- CALINA-IBD / CALINA-IBD
- Keywords
- Pregnancy, IBD, Crohn's Disease, Ulcerative Colitis, CALINA-IBD, Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- BC Children's Hospital Research Institute, IBD Centre of BC
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition that often presents during reproductive years, with approximately 25% of IBD patients having children after diagnosis. IBD during pregnancy can negatively impact infant health, as infants born to parents with IBD frequently exhibit higher fecal calprotectin (FCP) levels, a marker of gastrointestinal inflammation. Elevated FCP levels have been associated with increased risks of asthma, eczema, and IBD later in life. The purpose of this study is to examine how the maternal gut microbiome, diet, and breastmilk composition influence infant FCP levels and to identify factors that may guide dietary interventions to improve infant health outcomes. Specifically, the study aims to: (1) identify pregnancy-related maternal gut microbiota and dietary factors linked to elevated infant FCP levels, (2) determine infant gut microbiota and dietary factors associated with high FCP levels, (3) validate a supervised machine learning model capable of predicting high FCP levels in infants at 1 year of age using microbiota and dietary data, and (4) characterize human milk oligosaccharide (HMO) composition in breastmilk of mothers with and without IBD and its association with infant gut microbiota and FCP levels. This prospective study will evaluate changes in microbiota and dietary habits during and after pregnancy among maternal IBD patients (with active or quiescent disease) and non-IBD controls and their infants. Participants will be recruited during pregnancy (1st, 2nd, and early 3rd trimesters), and data and samples will be collected at four timepoints: 3rd trimester (week 34-35), 2 weeks postpartum, 3 months postpartum, and 1 year postpartum. Collected data will include 3-day dietary recalls, maternal and infant stool samples (for microbiota composition and FCP levels), optional breastmilk and breast skin swabs, vaginal swabs, and pregnancy and infant outcomes. These data will be integrated into a machine learning model to predict high infant FCP levels at 1 year, considering known covariates and factors identified in this study. The primary outcome is to determine the association between maternal gut microbiota composition-specifically the abundance of anti-inflammatory bacteria such as Faecalibacterium and Bifidobacterium-during the third trimester and early postpartum period, and infant FCP levels at 3 months and 1 year, accounting for maternal adherence to Mediterranean dietary patterns. Secondary outcomes include developing and validating a machine learning model for predicting elevated infant FCP at 1 year, characterizing and comparing HMO profiles between IBD and non-IBD mothers and their associations with infant gut microbiota and FCP levels, comparing pregnancy outcomes between mothers with ulcerative colitis, Crohn's disease, and non-IBD controls-including the impact of IBD therapy and mode of delivery-and examining the associations between maternal diet, microbiota composition (gut, skin, and vaginal), and pregnancy and infant outcomes across all study timepoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- All patients
- Inability to provide consent
- Previous gastrointestinal cancer or bowel surgery
- Renal disease
- HIV/AIDS or other serious infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
4 secondary outcomes
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.
Time frame: 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.
Time frame: 24 months
Compare pregnancy outcomes between mothers with ulcerative colitis or Crohn's disease and those without IBD.
Time frame: 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.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Lunken Lab WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD (Inflammatory Bowel Disease) and IBD, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Genelle Lunken, PhD, RD (7782327016, genelle.lunken@bcchr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.