Actively Recruiting
Comparative Assessment of Reflux Esophagitis in Cases With and Without Esophageal Motility Disorders
Led by Asian Institute of Gastroenterology, India · Updated on 2026-06-03
200
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Achalasia is a disorder affecting the movement of the esophagus and the relaxation of the lower esophageal sphincter, likely caused by nerve damage. This trial compares the features of reflux-related erosions after a treatment called per-oral endoscopic myotomy (POEM) with those in people who have reflux disease but no esophageal motility disorders. The study seeks to better understand the differences in esophagitis between these groups. Participants receiving POEM will be treated using a standardized method and given a single daily dose of an anti-secretory medication like esomeprazole for two months after the procedure. They will be followed for at least three months, during which proton pump inhibitors will be stopped for four weeks before assessment. Follow-up includes symptom questionnaires, endoscopy, and 24-hour pH monitoring to evaluate esophagitis and reflux characteristics. These findings will be compared with those from patients diagnosed with gastroesophageal reflux disease without motility disorders. During the study, participants will provide demographic and clinical data, and undergo pre- and post-treatment manometry. After three months, they will complete reflux symptom questionnaires and have an endoscopy and pH impedance test to measure esophageal acid exposure and observe esophagitis. Researchers will assess the size, type, and location of esophageal erosions to compare outcomes. The study spans from initial treatment through a six-month assessment period to monitor reflux and esophageal changes.
CONDITIONS
Brief Title
Comparative Assessment of Esophagitis in Cases With and Without Esophageal Motility Disorders: A Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of achalasia
- No contraindication to POEM procedure
- Presence of erosive esophagitis seen on endoscopy
You will not qualify if you...
- Having esophageal motility disorders other than achalasia
- Receiving treatments other than POEM
- Current use of proton pump inhibitors before GERD assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 months
Participants undergo the Per oral endoscopy myotomy (POEM) procedure and receive a single dose anti-secretory medicine (equivalent to 40 mg esomeprazole) daily for two months following the procedure.
1 procedure visit and daily medication for 2 months
Duration - 3 months
Participants are followed up after 3 months with several examinations including GERD questionnaire scoring, Esophagogastroduodenoscopy, and 24-hour pH impedance test to assess reflux esophagitis and esophageal acid exposure.
1 follow-up visit after 3 months
Trial Site Locations
Total: 1 location
1
Asian Institute of Gastroenterology Hospital
Hyderabad, Telangana, India, 500082
Actively Recruiting
Research Team
R
Rajesh Goud Mr Maragoni, M.Pharm, MBA
Z
Zaheer Nabi Dr Mohammed, MBBS MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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