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Blood test may guide diet to treat esophagitis

NCT ID NCT05543512

Disease control Sponsor: University of North Carolina, Chapel Hill 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

Summary

This study tested whether a personalized diet, based on a blood test that identifies food allergies, can help people with eosinophilic esophagitis (EoE). 56 participants were randomly assigned to either a personalized elimination diet or a sham diet. The goal was to see if the personalized diet could reduce inflammation in the esophagus and improve swallowing symptoms.

What this could mean

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

Active substance
personalized diet based on immune signature algorithm
What this could lead to
If successful, this could lead to a more effective, personalized dietary treatment for eosinophilic esophagitis, reducing the need for trial-and-error elimination diets.
What could go wrong
This is a small pilot study, so results may not apply to everyone. The algorithm may not accurately identify trigger foods, and the diet could be difficult to follow.

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

68 people

The number who actually took part.

Started

Oct 2022

Finished

Dec 2025

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

16 to 80 years

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: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Age: 16 - 80 years * Diagnosis of EoE as per consensus guidelines * No prior treatment with, or documented failure of, dietary elimination therapy. Failure is defined as =\>15 eos/hpf after a course of the six-food elimination diet (SFED). * On stable diet for 4 weeks prior to screening endoscopy and agree to maintain throughout course of participation. Foods eliminated for allergic or other reactions are not exclusionary and may continue to be avoided throughout participation in the study regardless of food trigger results. In addition to meeting the above criteria, to be eligible for randomization an individual must meet all of the following criteria: * Active EoE (=\>15 eos/hpf) based on clinical biopsies taken during baseline endoscopy * Must have at least one positive food on the IgG4 or T cell stimulation assay Exclusion Criteria: * Concomitant eosinophilic gastritis and/or enteritis, confirmed with a prior clinicohistologic diagnosis * Use of systemic corticosteroids within 4 weeks of the baseline/qualifying endoscopic exam * Previous esophageal resection * History of bleeding disorder or esophageal varices * Current use of blood thinners such as coumadin, warfarin, heparin, and/or novel anticoagulant agents (requires discontinuation of medication within an appropriate time frame for that specific agent and in accordance with standard clinical practice) * Medical instability that precludes safely performing upper endoscopy * Inability to read or understand English * Pregnancy or breastfeeding * Body mass index (BMI) \<17

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Conditions

The condition(s) this trial relates to.

eosinophilic esophagitis

As listed by the trial registrant

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

EOE Eosinophilic esophagitis

Contacts and locations

Locations

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

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