Esophagogastric Junction Outflow ObstructionEarly Phase 1NCT06588348
Corticosteroid Effect on Achalasia Variant EGJOO
A Early Phase 1 study testing Steroid treatment, Esophageal Manometry and Survey in people with Esophagogastric Junction Outflow Obstruction, run by Baylor Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagogastric Junction Outflow Obstruction
- What is being tested?
- Steroid treatment, Esophageal Manometry and Survey
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2022to Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: 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.
Read the 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.
- Being tested
- Steroid treatment, Esophageal Manometry, Survey
- Keywords
- EGJOO, Corticosteroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid treatmentDrug
Also called Prednisone
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.
Esophageal ManometryProcedure or surgery
On the final day of Prednisone use, all subjects will undergo esophageal manometry testing to assess for treatment response.
SurveyOther
Also called Eckardt and Brief Esophageal Dysphagia Questionnaire (BEDQ)
All enrolled subjects will be asked to complete follow-up Eckardt and BEDQ surveys.
| Study group | Role | What they receive |
|---|---|---|
| Steroid Treatment | Experimental | 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. Receives: Drug: Steroid treatment; Procedure: Esophageal Manometry; Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response in esophageal motility to study intervention
Median integrated relaxation pressure (IRP) of the lower esophageal sphincter (LES) obtained through esophageal manometry procedure
Measured: Assessed upon being on study intervention medication for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start26 Jul 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Esophagogastric Junction Outflow ObstructionStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chanakyaram Reddy, Baylor Research Institute
- Investigators
- Chanakyaram Reddy, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588348
- Sponsor's protocol ID
- 022-001 Steroid Study
- Status last verified
- Jan 2026
- First submitted
- 23 Aug 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yadlapati R, Kahrilas PJ, Fox MR, Bredenoord AJ, Prakash Gyawali C, Roman S, Babaei A, Mittal RK, Rommel N, Savarino E, Sifrim D, Smout A, Vaezi MF, Zerbib F, Akiyama J, Bhatia S, Bor S, Carlson DA, Chen JW, Cisternas D, Cock C, Coss-Adame E, de Bortoli N, Defilippi C, Fass R, Ghoshal UC, Gonlachanvit S, Hani A, Hebbard GS, Wook Jung K, Katz P, Katzka DA, Khan A, Kohn GP, Lazarescu A, Lengliner J, Mittal SK, Omari T, Park MI, Penagini R, Pohl D, Richter JE, Serra J, Sweis R, Tack J, Tatum RP, Tutuian R, Vela MF, Wong RK, Wu JC, Xiao Y, Pandolfino JE. Esophageal motility disorders on high-resolution manometry: Chicago classification version 4.0(c). Neurogastroenterol Motil. 2021 Jan;33(1):e14058. doi: 10.1111/nmo.14058.
PubMed 33373111Richter JE, Clayton SB. Diagnosis and Management of Esophagogastric Junction Outflow Obstruction. Am J Gastroenterol. 2019 Apr;114(4):544-547. doi: 10.14309/ajg.0000000000000100. No abstract available.
PubMed 30848733Sadowski DC, Ackah F, Jiang B, Svenson LW. Achalasia: incidence, prevalence and survival. A population-based study. Neurogastroenterol Motil. 2010 Sep;22(9):e256-61. doi: 10.1111/j.1365-2982.2010.01511.x. Epub 2010 May 11.
PubMed 20465592Enestvedt BK, Williams JL, Sonnenberg A. Epidemiology and practice patterns of achalasia in a large multi-centre database. Aliment Pharmacol Ther. 2011 Jun;33(11):1209-14. doi: 10.1111/j.1365-2036.2011.04655.x. Epub 2011 Apr 11.
PubMed 21480936Okeke FC, Raja S, Lynch KL, Dhalla S, Nandwani M, Stein EM, Chander Roland B, Khashab MA, Saxena P, Kumbhari V, Ahuja NK, Clarke JO. What is the clinical significance of esophagogastric junction outflow obstruction? evaluation of 60 patients at a tertiary referral center. Neurogastroenterol Motil. 2017 Jun;29(6). doi: 10.1111/nmo.13061. Epub 2017 Apr 9.
PubMed 28393437Schupack D, Katzka DA, Geno DM, Ravi K. The clinical significance of esophagogastric junction outflow obstruction and hypercontractile esophagus in high resolution esophageal manometry. Neurogastroenterol Motil. 2017 Oct;29(10):1-9. doi: 10.1111/nmo.13105. Epub 2017 May 23.
PubMed 28544670Clayton SB, Patel R, Richter JE. Functional and Anatomic Esophagogastic Junction Outflow Obstruction: Manometry, Timed Barium Esophagram Findings, and Treatment Outcomes. Clin Gastroenterol Hepatol. 2016 Jun;14(6):907-911. doi: 10.1016/j.cgh.2015.12.041. Epub 2016 Jan 12.
PubMed 26792374Samo S, Qayed E. Esophagogastric junction outflow obstruction: Where are we now in diagnosis and management? World J Gastroenterol. 2019 Jan 28;25(4):411-417. doi: 10.3748/wjg.v25.i4.411.
PubMed 30700938Vaezi MF, Pandolfino JE, Yadlapati RH, Greer KB, Kavitt RT. ACG Clinical Guidelines: Diagnosis and Management of Achalasia. Am J Gastroenterol. 2020 Sep;115(9):1393-1411. doi: 10.14309/ajg.0000000000000731.
PubMed 32773454Nelson M, Zhang X, Genta RM, Turner K, Podgaetz E, Paris S, Cardenas J, Gu J, Leeds S, Ward M, Nguyen A, Konda V, Furuta GT, Pan Z, Souza RF, Spechler SJ. Lower esophageal sphincter muscle of patients with achalasia exhibits profound mast cell degranulation. Neurogastroenterol Motil. 2021 May;33(5):e14055. doi: 10.1111/nmo.14055. Epub 2020 Dec 6.
PubMed 33280206
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Effect on Achalasia Variant Esophagogastric Junction Outflow Obstruction
- ClinicalTrials.gov ID
- NCT06588348
- Acronym / sponsor ID
- 022-001 Steroid Study
- Keywords
- EGJOO, Corticosteroid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Steroid Treatment | Experimental | Drug: Steroid treatment, Procedure: Esophageal Manometry, Other: SurveyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steroid treatmentAlso: PrednisoneAll 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. | Drug | Steroid Treatment |
| Esophageal ManometryOn the final day of Prednisone use, all subjects will undergo esophageal manometry testing to assess for treatment response. | Procedure or surgery | Steroid Treatment |
| SurveyAlso: Eckardt and Brief Esophageal Dysphagia Questionnaire (BEDQ)All enrolled subjects will be asked to complete follow-up Eckardt and BEDQ surveys. | Other | Steroid Treatment |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 33373111Yadlapati R, Kahrilas PJ, Fox MR, Bredenoord AJ, Prakash Gyawali C, Roman S, Babaei A, Mittal RK, Rommel N, Savarino E, Sifrim D, Smout A, Vaezi MF, Zerbib F, Akiyama J, Bhatia S, Bor S, Carlson DA, Chen JW, Cisternas D, Cock C, Coss-Adame E, de Bortoli N, Defilippi C, Fass R, Ghoshal UC, Gonlachanvit S, Hani A, Hebbard GS, Wook Jung K, Katz P, Katzka DA, Khan A, Kohn GP, Lazarescu A, Lengliner J, Mittal SK, Omari T, Park MI, Penagini R, Pohl D, Richter JE, Serra J, Sweis R, Tack J, Tatum RP, Tutuian R, Vela MF, Wong RK, Wu JC, Xiao Y, Pandolfino JE. Esophageal motility disorders on high-resolution manometry: Chicago classification version 4.0(c). Neurogastroenterol Motil. 2021 Jan;33(1):e14058. doi: 10.1111/nmo.14058.
- Background: PubMed 30848733Richter JE, Clayton SB. Diagnosis and Management of Esophagogastric Junction Outflow Obstruction. Am J Gastroenterol. 2019 Apr;114(4):544-547. doi: 10.14309/ajg.0000000000000100. No abstract available.
- Background: PubMed 20465592Sadowski DC, Ackah F, Jiang B, Svenson LW. Achalasia: incidence, prevalence and survival. A population-based study. Neurogastroenterol Motil. 2010 Sep;22(9):e256-61. doi: 10.1111/j.1365-2982.2010.01511.x. Epub 2010 May 11.
- Background: PubMed 21480936Enestvedt BK, Williams JL, Sonnenberg A. Epidemiology and practice patterns of achalasia in a large multi-centre database. Aliment Pharmacol Ther. 2011 Jun;33(11):1209-14. doi: 10.1111/j.1365-2036.2011.04655.x. Epub 2011 Apr 11.
- Background: PubMed 28393437Okeke FC, Raja S, Lynch KL, Dhalla S, Nandwani M, Stein EM, Chander Roland B, Khashab MA, Saxena P, Kumbhari V, Ahuja NK, Clarke JO. What is the clinical significance of esophagogastric junction outflow obstruction? evaluation of 60 patients at a tertiary referral center. Neurogastroenterol Motil. 2017 Jun;29(6). doi: 10.1111/nmo.13061. Epub 2017 Apr 9.
- Background: PubMed 28544670Schupack D, Katzka DA, Geno DM, Ravi K. The clinical significance of esophagogastric junction outflow obstruction and hypercontractile esophagus in high resolution esophageal manometry. Neurogastroenterol Motil. 2017 Oct;29(10):1-9. doi: 10.1111/nmo.13105. Epub 2017 May 23.
- Background: PubMed 26792374Clayton SB, Patel R, Richter JE. Functional and Anatomic Esophagogastic Junction Outflow Obstruction: Manometry, Timed Barium Esophagram Findings, and Treatment Outcomes. Clin Gastroenterol Hepatol. 2016 Jun;14(6):907-911. doi: 10.1016/j.cgh.2015.12.041. Epub 2016 Jan 12.
- Background: PubMed 30700938Samo S, Qayed E. Esophagogastric junction outflow obstruction: Where are we now in diagnosis and management? World J Gastroenterol. 2019 Jan 28;25(4):411-417. doi: 10.3748/wjg.v25.i4.411.
- Background: PubMed 32773454Vaezi MF, Pandolfino JE, Yadlapati RH, Greer KB, Kavitt RT. ACG Clinical Guidelines: Diagnosis and Management of Achalasia. Am J Gastroenterol. 2020 Sep;115(9):1393-1411. doi: 10.14309/ajg.0000000000000731.
- Background: PubMed 33280206Nelson M, Zhang X, Genta RM, Turner K, Podgaetz E, Paris S, Cardenas J, Gu J, Leeds S, Ward M, Nguyen A, Konda V, Furuta GT, Pan Z, Souza RF, Spechler SJ. Lower esophageal sphincter muscle of patients with achalasia exhibits profound mast cell degranulation. Neurogastroenterol Motil. 2021 May;33(5):e14055. doi: 10.1111/nmo.14055. Epub 2020 Dec 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chanakyaram Reddy, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Steroid treatment, Esophageal Manometry and Survey in people with Esophagogastric Junction Outflow Obstruction, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response in esophageal motility to study intervention (time frame: Assessed upon being on study intervention medication for 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06588348, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.