Mechanisms of Weight Loss in Patients Diagnosed With Achalasia
Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Feb 21, 2017
Trial Information
Current as of July 24, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Patients either diagnosed with or being evaluated for achalasia and scheduled for standard clinic visits with the principal investigator as part of their routine care will be considered for participation in this study. Blood work, vital signs, and 24-hour dietary recall will be collected over a period of one year. These data will lay the foundation for future scientific endeavors to : a) assess requirements for dietary and/or nutritional supplements; b) formulate an achalasia diet; c) develop clinical practice standards; and d) design an intervention study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Subject is able to provide written informed consent to participate in the study before completing any study-related procedures
- • 2. Subject is male or female aged 18-75 years, inclusive at time of consent.
- • 3. Subject has a documented diagnosis of achalasia based on high resolution manometry and endoscopy report.
- • 4. Subject has been or will be scheduled to undergo either EGD with pneumatic dilation or surgical myotomy as routine care for treatment of achalasia.
- • 5. Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
- Exclusion Criteria:
- • 1. Subject has any condition or abnormality, current or past that, in the opinion of the principal investigator, would compromise the safety of the subject or interfere with or complicate the assessment of signs or symptoms of achalasia. Such conditions may include psychiatric problems; neurologic deficits or disease; developmental delay; lung transplant; or previous gastroesophageal surgery.
- • 2. Subject has had previous pneumatic dilation of treatment of achalasia.
- • 3. Subject has had botulinum toxin (botox) injection for treatment of achalasia.
- • 4. Subject has a history or high risk of noncompliance with treatment or regular clinic visits.
About Vanderbilt University Medical Center
Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nashville, Tennessee, United States
Patients applied
Trial Officials
Michael Vaezi, MD,PhD
Principal Investigator
Vanderbilt University Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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