Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06835374

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

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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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

Follow-up

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

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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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