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Early Gluten-Free diet or probiotics: a new strategy to prevent celiac disease?

NCT ID NCT03562221

Prevention Sponsor: Lund University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

Researchers are testing whether a gluten-free diet during the first three years of life, or daily probiotic supplements, can prevent celiac disease in children with a high genetic risk. The trial enrolls infants before they start eating gluten and randomly assigns them to one of three groups: gluten-free diet, probiotics, or placebo. Children are followed with regular blood tests until age 7 to see if they develop celiac disease autoimmunity or celiac disease.

What this could mean

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

Active substance
Gluten-free diet or probiotic capsules
What this could lead to
If successful, this could point toward a way to prevent celiac disease in children with a genetic risk.
What could go wrong
The trial is small and early, and results may not apply to all children. The gluten-free diet is demanding, and probiotics may not offer the hoped-for protection.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

220 people

The number who actually took part.

Started

Dec 2018

Expected to finish

Aug 2030

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.

Ages

4 to 4 months

Sex

Anyone

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: * Children screened positive for human leucocyte antigen (HLA) DR3-DQ2/DR3-DQ2 * Children must be enrolled to the study by 4 months of age (before gluten consumption has started). Exclusion Criteria: * Congenital chronic disorder where intervention with diet or probiotics may be affected. * Written consent from both caregivers are missing

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Conditions

The condition(s) this trial relates to.

celiac disease

As listed by the trial registrant

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

Celiac disease in children

Contacts and locations

Locations

  • Clinical Research Center (CRC), Bldng 60:11

    Malmö, 20502, Sweden

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