Corticosteroid Effect on Achalasia Variant EGJOO

January 27, 2026 updated by: Chanakyaram Reddy, Baylor Research Institute

Corticosteroid Effect on Achalasia Variant Esophagogastric Junction Outflow Obstruction

EGJOO is a disorder in which the muscles of the esophagus (swallowing tube) do not function in a coordinated fashion so that swallowed material does not pass easily into the stomach. EGJOO often causes symptoms of swallowing difficulties and chest pain. The cause of EGJOO and its optimal treatment are not clear. The investigators research team suspects that EGJOO might be caused by an allergy that involves the esophagus, and that treatment with medications called corticosteroids might improve function of the esophageal muscles. The purpose of this study is to learn how corticosteroid therapy affects the muscles of the esophagus in patients suffering with EGJOO.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Esophagogastric junction outflow obstruction (EGJOO) is an esophageal motility disorder with a heterogeneous etiology. The optimal treatment for EGJOO is not known, and proper management of the condition remains disputed. Similar to patients with achalasia, patients with EGJOO exhibit poor relaxation of the lower esophageal sphincter (LES) with swallowing. Unlike patients with achalasia, however, those with EGJOO have some intact peristalsis in the esophageal body. Achalasia treatments (pneumatic dilation, Heller myotomy, per-oral endoscopic myotomy [POEM]) attempt to destroy LES muscle contraction function with myotomy inflicted by balloon distention (pneumatic dilation), diathermic needle-knife (POEM), or scalpel (Heller myotomy). With POEM and Heller myotomy, the incision extends into muscle of the esophageal body. These same interventions have been used to treat EGJOO, but an effective, non-invasive therapy that does not involve muscle disruption would be preferable, especially since EGJOO patients have evidence of esophageal body peristalsis that might be destroyed by achalasia myotomy techniques. The investigators Center for Esophageal Diseases has recently described a possible allergic etiology for achalasia and EGJOO in a study in which the investigators found profound mast cell degranulation in the LES muscle in all of 13 patients with these disorders who were treated with Heller myotomy. The investigators have also published reports outlining the investigators rationale for considering an allergic etiology for achalasia and EGJOO. Now, an extension of this work is to assess whether corticosteroid therapy, which can improve allergic conditions, can correct the esophageal dysfunction in EGJOO to the point that invasive and irreversible myotomy treatments might not be required. The proposed study will enroll subjects with clinically significant EGJOO on the achalasia-variant spectrum, and treat them with a 14-day course of oral, systemic corticosteroid therapy. The investigators aim to describe the symptomatic and manometric response to corticosteroid therapy, and hypothesize that the investigators findings might establish that a subset of patients with EGJOO have a reversible form of esophageal muscle dysfunction. Although long-term treatment with corticosteroids has unacceptable toxicity, identification of a reversible form of EGJOO with a short course of steroid therapy would suggest a therapeutic role for other, less toxic, allergy-directed therapies.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Adult patients age 18 years or older with the following clinical and diagnostic criteria will be eligible for study inclusion:

  • EGJOO manometric diagnosis based on CC v4.0 criteria
  • Primary symptom of dysphagia and/or non-cardiac chest pain
  • Additional objective evidence of obstruction on Timed Barium Esophagram and/or EndoFLIP
  • The treating physician has determined that invasive therapy (botulinum toxin injection, pneumatic dilation, POEM, or Heller myotomy) is indicated.

Exclusion Criteria:

  • History of prior foregut surgery
  • History of esophageal botulinum toxin injection within 6 months of study enrollment
  • Presence of hiatal hernia > 2 centimeters
  • Presence of esophageal mass
  • Obstructing esophageal stricture or ring on endoscopy
  • Reflux esophagitis (LA Grades B-D)
  • Subjects on current immunosuppression or immune modulating therapy
  • Chronic opioid use
  • Previously diagnosed extrinsic compression of the gastroesophageal junction
  • Concomitant Eosinophilic Esophagitis with uncontrolled mucosal disease who have not tried at least one standard therapy
  • Contraindication to the use of oral corticosteroids
  • History and/or current diagnosis of Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Steroid Treatment
All participants are in the treatment arm. Patients with Esophagogastric Junction Outflow Obstruction (EGJOO) will undergo steroid treatment for 14 days. On the last day of the 14 day treatment, patient will undergo esophageal manometry testing to assess for treatment response. They will also be asked to complete follow-up Eckardt and BEDQ surveys.
Drug: Steroid treatment
All enrolled subjects will be prescribed a 14-day course of corticosteroid therapy in the form of Prednisone 20 mg to be taken once daily by mouth.
Other Names:
  • Prednisone
Procedure: Esophageal Manometry
On the final day of Prednisone use, all subjects will undergo esophageal manometry testing to assess for treatment response.
Other: Survey
All enrolled subjects will be asked to complete follow-up Eckardt and BEDQ surveys.
Other Names:
  • Eckardt and Brief Esophageal Dysphagia Questionnaire (BEDQ)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response in esophageal motility to study intervention
Time Frame: Assessed upon being on study intervention medication for 14 days
Median integrated relaxation pressure (IRP) of the lower esophageal sphincter (LES) obtained through esophageal manometry procedure
Assessed upon being on study intervention medication for 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: Chanakyaram Reddy, MD, Baylor Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

September 4, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022-001 Steroid Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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