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Can gut bacteria predict celiac disease? new study follows At-Risk infants

NCT ID NCT02061306

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 500 infants who have a close family member with celiac disease. Researchers track their genes, diet, gut bacteria, and other factors from birth to see what leads to the disease. The goal is to find ways to predict or prevent celiac disease in children who are at high risk.

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 help identify early warning signs or risk factors for celiac disease, potentially leading to ways to prevent or detect it earlier in high-risk children.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test any therapy, and results may take years to translate into practical advice or interventions.

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 500 people

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

Start date

Mar 2014

Expected to finish

Dec 2027

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

Newborns and infants younger than 6 months who are first-degree relatives of CD patients (at least one parent or sibling affected with biopsy-proven CD) are eligible for participation.

Ages

Up to 6 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Newborns and infants less than 6 months of age who have not been introduced to solid foods (exclusive breast milk or formula diet) * First-degree relatives of patients affected with biopsy-proven CD Exclusion Criteria: * Infants older than 6 months of age * Inability or unwillingness of legal guardian/representative to give written informed consent

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Conditions

The condition(s) this trial relates to.

celiac disease prevention target

As listed by the trial registrant

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

Celiac disease

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 in 2 countries. 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

  • MassGeneral Hospital for Children

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • University of Roma La Sapienza

    RECRUITING

    Rome, 00185, Italy

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