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Biological Optimization Versus Standard Care in Post-POEM Achalasia Patients (BIO-POEM)
Sponsor: Asian Institute of Gastroenterology, India
Summary
This study aims to evaluate whether a structured biological optimization program can improve reflux symptoms and overall recovery in patients with achalasia cardia who previously underwent Peroral Endoscopic Myotomy (POEM). Although POEM is highly effective for relieving swallowing difficulty, many patients develop gastroesophageal reflux disease (GERD) after the procedure and remain dependent on long-term acid suppressive medications such as proton pump inhibitors (PPIs). The BIO-POEM study will compare structured biological optimization with standard post-POEM care in patients with objectively confirmed pathological reflux after POEM. The intervention includes reflux-oriented dietary counseling, micronutrient assessment and correction, Helicobacter pylori testing and eradication when indicated, lifestyle optimization, and structured review and tapering of PPI/PCAB therapy. The study includes two components: A randomized controlled trial enrolling post-POEM patients with objectively confirmed reflux. A parallel prospective observational registry enrolling symptomatic post-POEM patients who are unable to undergo reflux testing or who remain symptomatic despite low acid exposure. The primary objective is to determine whether structured biological optimization reduces GERD symptom burden at 12 months compared with standard care. Secondary objectives include evaluation of dyspepsia symptoms, nutritional recovery, quality of life, reduction in PPI dependence, and exploratory assessment of gut microbiome changes.
Official title: Randomized Controlled Trial of Structured Biological Optimization Versus Standard Care With Embedded Prospective Registry in Post-POEM Achalasia Cardia Patients.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
166
Start Date
2026-05-20
Completion Date
2028-12-20
Last Updated
2026-06-02
Healthy Volunteers
No
Interventions
Structured Biological Optimization
A structured, protocol-driven multimodal intervention designed to optimize post-POEM recovery in patients with achalasia cardia. The intervention includes individualized reflux-oriented dietary counseling (meal timing, portion control, and trigger food modification), lifestyle optimization (sleep hygiene, weight management, and physical activity guidance), systematic evaluation and correction of micronutrient deficiencies (including vitamin D, vitamin B12, iron, calcium, magnesium, and pre-albumin where indicated), Helicobacter pylori testing with eradication therapy when positive, and a structured, stepwise protocol for proton pump inhibitor (PPI) or potassium-competitive acid blocker (PCAB) de-escalation guided by symptoms and clinical assessment. The intervention is delivered as a standardized care pathway integrated into routine post-POEM follow-up.
Locations (1)
Asian Institute of Gastroenterology
Hyderabad, Telangana, India