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A Super-Microscope could spot acid reflux in Kids—Without guesswork?

NCT ID NCT01921686

Diagnosis Sponsor: Baylor College of Medicine 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 This study
Paused for now. It may or may not start again.
Ongoing
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This study explores whether a very high-powered microscope can help diagnose acid reflux disease (GERD) in children by examining tiny gaps between cells in the esophagus. Researchers will compare biopsy samples from children with GERD, those with a related condition called eosinophilic esophagitis, and healthy controls. The goal is to see if these gaps, called dilated intercellular spaces, are a reliable marker for GERD, potentially offering a more precise diagnostic tool.

What this could mean

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

Active substance
Esophageal biopsy samples analyzed with transmission electron microscopy (TEM)
What this could lead to
If successful, this could lead to a more accurate, objective way to diagnose acid reflux in children, reducing reliance on subjective symptoms and pH monitoring.
What could go wrong
This is an observational study with a small sample size, so the findings may not apply to all children. The technique requires invasive biopsies and specialized equipment, limiting its widespread use.

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

54 people

The number who actually took part.

Start date

Mar 2013

Expected to finish

Dec 2026

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.

Who is studied

Children between the ages of 8-18 years scheduled for endoscopy for clinical indication.

Ages

8 to 18 years

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 for GERD or EoE Subjects: * Children between the ages of 8-18 years * Suspected diagnosis of GERD or EoE based on symptom criteria * Able to tolerate upper endoscopy examination with biopsies Inclusion Criteria for Control Subjects: * Children between the ages of 8-18 * Scheduled for EGD for clinical indications * No history of esophageal disease of esophageal symptoms * Able to tolerate upper endoscopy examination with biopsies Exclusion Criteria for GERD or EoE Subjects: * History of Barrett's esophagus * Previous esophageal or gastric surgery * History of congenital defect/malformation of the esophagus * Diagnosis of Crohn disease Exclusion Criteria for Control Subjects: * Symptoms of GERD or EoE (including heartburn, regurgitation, difficulty swallowing, painful swallowing).

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Conditions

The condition(s) this trial relates to.

Deglutition Disorders eosinophilic esophagitis food allergy gastroesophageal reflux disease

As listed by the trial registrant

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

Eosinophilic esophagitis Gastroesophageal reflux disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

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