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Mediterranean diet in pregnancy may shield babies from allergies

NCT ID NCT05119868

Prevention Sponsor: Federico II 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Updated 2 times

Summary

This study is testing whether following a Mediterranean diet during pregnancy can reduce the chance of children developing allergies by age 2. Researchers are enrolling 276 healthy pregnant women (ages 20-35) who are at risk of having a baby with allergies. Participants receive personalized nutrition counseling and a tailored Mediterranean diet plan. The main goal is to see if this dietary approach lowers allergy rates in the offspring.

What this could mean

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

Active substance
Mediterranean diet (personalized nutritional counseling and tailored diet)
What this could lead to
If it works, this could point toward a simple dietary approach to reduce the risk of allergies in children.
What could go wrong
This is a relatively small trial (276 participants) and results may not apply to all populations. Dietary interventions are hard to control, and the effect may be modest or not statistically significant.

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

276 people

The number who actually took part.

Started

Nov 2021

Finished

Mar 2026

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

20 to 35 years

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: \- healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby Exclusion Criteria: * concomitant presence of infections; * concomitant presence of malignancies; * concomitant presence of major gastrointestinal malformations; * concomitant presence of immunodeficiencies; * concomitant presence of autoimmune diseases; * concomitant presence of chronic inflammatory bowel diseases; * concomitant presence of functional gastrointestinal disorders; * concomitant presence of celiac disease; * history of abdominal surgery with gastrointestinal resection; * concomitant presence of neuropsychiatric disorders; * concomitant presence of central nervous system disorders; * vegan diet; * twin pregnancy; * concomitant presence of genetic disorders; * concomitant presence of metabolic disorders.

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Conditions

The condition(s) this trial relates to.

Birth Weight Breast Feeding Gestational Weight Gain Obesity obesity disorder perinatal disease pregnancy disorder allergic disease prevention target

As listed by the trial registrant

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

Allergies Birth weight Breast feeding Chronic diseases in children Gestational complications Gestational weight gain Obesity Perinatal condition

Contacts and locations

Locations

  • Department of Traslational Medical Science

    Naples, Italy, 80131, Italy

  • Department of Traslational Medical Science - University of Naples Federico II

    Naples, Naples, 80131, Italy

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