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Could Mom's microbiome shape Baby's gut health? new study investigates

NCT ID NCT07385807

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how the bacteria and diet of pregnant women with inflammatory bowel disease (IBD) may influence gut inflammation in their babies. Researchers will collect samples from 80 mothers and infants over a year to track gut microbes and diet. The goal is to find patterns that could lead to better infant health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could identify dietary patterns or microbiome features that help reduce gut inflammation in infants born to mothers with IBD.
What could go wrong
This is a small, early-stage observational study, so it cannot prove cause and effect. Results may not apply to all families with IBD.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

19 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BC Children's Hospital Research Institute

    NOT_YET_RECRUITING

    Vancouver, British Columbia, V5Z 4H4, Canada

  • BC Children's Hospital Research Institute

    RECRUITING

    Vancouver, British Columbia, V5Z 4H4, Canada

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