An Early Phase 1 interventional study of Steroid treatment and Esophageal Manometry in Esophagogastric Junction Outflow Obstruction, sponsored by Baylor Research Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Baylor Research Institute · Early Phase 1, Interventional, and Basic science
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.
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.
Baylor Research Institute is the lead sponsor of 219 studies on the registry; 49 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
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Inclusion Criteria: Adult patients age 18 years or older with the following clinical and diagnostic criteria will be eligible for study inclusion:
Exclusion Criteria:
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 · Procedure: Esophageal Manometry · Other: Survey
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.
Also known as: Prednisone
On the final day of Prednisone use, all subjects will undergo esophageal manometry testing to assess for treatment response.
All enrolled subjects will be asked to complete follow-up Eckardt and BEDQ surveys.
Also known as: Eckardt and Brief Esophageal Dysphagia Questionnaire (BEDQ)
Response in esophageal motility to study intervention
Median integrated relaxation pressure (IRP) of the lower esophageal sphincter (LES) obtained through esophageal manometry procedure
Time frame: Assessed upon being on study intervention medication for 14 days
Plan to share: No
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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