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Could gut bacteria hold the key to food allergies?

NCT ID NCT02087930

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Researchers are studying the gut bacteria of infants with cow milk allergy compared to healthy infants. They aim to see if differences in the types and functions of gut microbes are linked to food allergy. The study includes 600 children aged 6 to 12 months and also compares children from Italy with those from other countries. This research may help explain how gut bacteria influence allergy development and could guide future prevention or treatment strategies.

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 differences in gut bacteria are found, this could point toward probiotic-based strategies to prevent or treat food allergies in children.
What could go wrong
This is an observational study, so it cannot prove that gut bacteria cause or cure allergies. Any link found may be coincidental, and more research would be needed before any treatment is developed.

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

600 people

The number who actually took part.

Start date

Mar 2013

Finished

Sep 2020

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 12 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 with cow's milk allergy * age 6-12 months Exclusion Criteria: * concomitant chronic systemic diseases * congenital cardiac defects * active tuberculosis * autoimmune diseases * immunodeficiency * chronic inflammatory bowel diseases * celiac disease, cystic fibrosis * metabolic diseases * malignancy * chronic pulmonary diseases * malformations of the gastrointestinal tract * suspected eosinophilic esophagitis or eosinophilic enterocolitis * suspected food-protein-induced enterocolitis syndrome.

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Conditions

The condition(s) this trial relates to.

Heiner syndrome Milk Hypersensitivity

As listed by the trial registrant

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

Cow milk allergy

Contacts and locations

Locations

  • University of Naples Federico II

    Naples, Naples, 80131, Italy

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