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Low-gluten diet in toddlers may cut celiac risk, study finds

NCT ID NCT04593888

Prevention Sponsor: Lund University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looks at whether giving children with a genetic risk for celiac disease a low-gluten diet (less than 3 grams per day) during their first three years of life can lower their chance of developing the disease by age 7. About 1,100 children from Sweden are taking part. The goal is to see if this simple dietary change can prevent celiac disease and related autoimmune conditions.

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

1,141 people

The number who actually took part.

Started

May 2021

Expected to finish

Dec 2035

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

6 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: * children screened positive for HLA DQ2/X (X is neither DQ2 or DQ8) * children who refused enrolment to the on-going study PreSiCe (ClinicalTrials.gov Identifier NCT03562221) Exclusion Criteria: * congenital chronic disorder where intervention with diet may be affected * written informed consent from both caregivers are missing

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Conditions

The condition(s) this trial relates to.

autoimmune disease type 1 diabetes mellitus celiac disease prevention target

As listed by the trial registrant

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

Autoimmune diseases Celiac disease in children TYPE1DIABETES

Contacts and locations

Locations

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

    Malmö, 20502, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.