Corticosteroids for Esophagogastric Junction Obstruction

CR
DS
Overseen ByDaniel S Kim, MS
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Baylor Research Institute
Must be taking: Corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether corticosteroids, a type of medication, can help people with a swallowing disorder called Esophagogastric Junction Outflow Obstruction (EGJOO). EGJOO hinders the smooth movement of food from the esophagus into the stomach, causing swallowing problems and chest pain. Researchers believe the condition might be linked to allergies affecting the esophagus, and corticosteroids could improve muscle function in the esophagus. The trial targets adults diagnosed with EGJOO who mainly experience swallowing issues or chest pain and are considering invasive treatments. As an Early Phase 1 trial, this research seeks to understand how corticosteroids work in people with EGJOO, offering participants a chance to explore this potential treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppression or immune modulating therapy, or if you have chronic opioid use.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that corticosteroids, a type of medication used to reduce swelling, might help people with Esophagogastric Junction Outflow Obstruction (EGJOO). In some studies, patients with similar esophageal problems have felt better after taking corticosteroids. For instance, one study found that people with a related condition experienced significant symptom relief after using steroids.

Corticosteroids are generally safe for short-term use, but they can cause side effects, especially with prolonged use. Common side effects include increased hunger, mood swings, and trouble sleeping. However, serious side effects are rare with short-term use, such as the 14-day treatment in this study.

This trial is in an early stage, aiming to learn more about how well this treatment works for EGJOO. The researchers are still collecting safety information, but past experiences with corticosteroids suggest they are usually manageable for most people. Prospective participants might find it helpful to discuss any concerns with their doctor.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about using corticosteroids for treating Esophagogastric Junction Outflow Obstruction (EGJOO) because this approach offers a novel mechanism of addressing the condition. Traditional treatments for EGJOO often involve mechanical interventions like dilation or surgery, which can be invasive and come with longer recovery times. In contrast, corticosteroids target inflammation directly, potentially reducing the obstruction more gently and quickly. This non-invasive method could provide a simpler, faster way to relieve symptoms and improve patient quality of life without the need for surgical procedures.

What evidence suggests that this treatment might be an effective treatment for EGJOO?

Research has shown that corticosteroids might alleviate symptoms of esophagogastric junction outflow obstruction (EGJOO). This condition impairs swallowing due to malfunctioning esophageal muscles. One study found that patients with achalasia, a similar condition characterized by an abundance of a certain type of white blood cell, experienced significant improvement after taking corticosteroids. Their swallowing improved, and their esophageal muscles functioned more effectively. This trial will assess the effects of steroid treatment on EGJOO, aiming to determine if corticosteroids can reduce inflammation and enhance muscle movement. However, further research is necessary to confirm these effects specifically for EGJOO.13456

Who Is on the Research Team?

CR

Chanakyaram Reddy, MD

Principal Investigator

Baylor Health Care System

Are You a Good Fit for This Trial?

This trial is for individuals with EGJOO, a condition where the esophagus muscles don't work well together, causing swallowing difficulties and chest pain. Participants must meet certain criteria not specified here.

Inclusion Criteria

Additional objective evidence of obstruction on Timed Barium Esophagram and/or EndoFLIP
I have difficulty swallowing and/or chest pain not related to heart issues.
My doctor recommends a specific procedure for my condition.
See 1 more

Exclusion Criteria

I cannot take oral corticosteroids due to health reasons.
I have had surgery on my upper digestive tract.
I am currently on medication that affects my immune system.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 14-day course of oral, systemic corticosteroid therapy

2 weeks
1 visit (in-person) for esophageal manometry testing on the last day

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of Eckardt and BEDQ surveys

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Steroid treatment
Trial Overview The study tests if corticosteroids can improve esophageal muscle function in EGJOO patients. It involves steroid treatment, measuring muscle movement with esophageal manometry, and completing surveys about symptoms.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Steroid TreatmentExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials
210
Recruited
205,000+

Citations

Corticosteroid Effect on Achalasia Variant EGJOO | MedPathThe 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 - PubMed CentralEsophagogastric junction outflow obstruction (EGJOO) is a major motility disorder based on the Chicago Classification of esophageal motility disorders.
Achalasia With Dense Eosinophilic Infiltrate Responds to ...The patient was given 50 mg prednisolone once daily; the symptoms improved dramatically, and HRIM showed complete recovery of esophageal peristalsis, deeper ...
Esophageal Motility Disorders: Current Approach to ...In this review, we discuss the current approach to diagnosis and therapeutics of various esophageal motility disorders.
Endoscopic Corticosteroid Injections Do Not Reduce ...Corticosteroid injections do not provide a statistically significant decrease in frequency of repeat dilations or prolongation of the dysphagia-free period in ...
Corticosteroid Effect on Achalasia Variant EGJOOThe cause of EGJOO and its optimal treatment are not clear. The investigators research team suspects that EGJOO might be caused by an allergy ...
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