Biological Optimization Versus Standard Care in Post-POEM Achalasia Patients (BIO-POEM)

NCT07620899 | Active Not Recruiting DMC

• 1 other identifier: BIO-POEM1
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Achalasia Cardia; GERD (Gastroesophageal Reflux Disease)

Keywords

Achalasia cardia; per oral endoscopic myotomy; GERD; Helicobacter pylori; Micronutrient deficiency

Outcome Measures

Primary Outcomes (1)

• Change in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Score From Baseline to 12 Months

  The primary outcome is the change in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score from baseline to 12 months after randomization in post-POEM patients with objectively confirmed pathological reflux. The GERD-HRQL questionnaire is a validated reflux-specific symptom assessment scale with total scores ranging from 0 to 50, where higher scores indicate worse reflux symptoms and poorer reflux-related quality of life.

  Baseline and 12 months

Secondary Outcomes (8)

• Proportion of Participants Successfully Discontinuing Proton Pump Inhibitor (PPI) or Potassium-Competitive Acid Blocker (PCAB) Therapy by 12 Months

  6 months and 12 months

• Change in Leeds Dyspepsia Questionnaire Score From Baseline to 6 and 12 Months

  Baseline, 6 months, and 12 months

• Change in Serum Vitamin D Levels From Baseline to 6 Months

  Baseline and 6 months

• Change in Serum Calcium Levels

  Baseline and 6 months

• Change in Serum Iron Levels

  Baseline and 6 months

Study Arms (2)

Structured Biological Optimization

EXPERIMENTAL

Participants in this arm will receive a structured, protocol-driven biological optimization program in addition to standard post-POEM follow-up. The intervention includes reflux-oriented dietary counseling, lifestyle modification, micronutrient assessment and correction (including vitamin D, B12, iron, calcium, and pre-albumin where deficient), Helicobacter pylori testing and eradication where indicated, and a structured, stepwise de-escalation of proton pump inhibitor (PPI) or potassium-competitive acid blocker (PCAB) therapy based on clinical response and physician assessment.

Dietary Supplement: Structured Biological Optimization

Standard Post-POEM Care

ACTIVE COMPARATOR

Participants in this arm will receive routine post-POEM care as practiced at the study center. Management will be symptom-driven and may include proton pump inhibitor (PPI) or PCAB therapy as clinically indicated. No structured dietary, micronutrient, or deprescribing protocol will be applied beyond standard clinical practice. Follow-up assessments and outcome evaluations will be performed in the same manner as the intervention arm.

Dietary Supplement: Structured Biological Optimization

Interventions

Structured Biological Optimization DIETARY_SUPPLEMENT

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.

Also known as: BIO-POEM Intervention, Post-POEM Biological Optimization Protocol, Structured Post-POEM Optimization Program BIO-POEM Care Pathway

Standard Post-POEM Care; Structured Biological Optimization

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above criteria plus AET\> 6% on pH impedance monitoring.
• Adults aged 18-70 years.
• Patients who stopped PPI/PCABs atleast 4 weeks prior to enrolment (to avoid false negative h.pylori test)
• Prior POEM performed between 6 months and 5 years before enrolment at AIG hospitals.
• Willingness to comply with lifestyle and nutritional interventions.
• Ability to provide written informed consent.
• Adults aged 18-70 years.
• Prior POEM performed between 6 months and 5 years before enrolment, at AIG hospitals.
• Clinically significant GERD symptoms after POEM. GERD-HRQL score ≥10, or
• reflux symptoms occurring ≥3 times per week, or
• current use of PPI/PCAB therapy for reflux symptom control
• reflux esophagitis on endoscopy.
• Unable to undergo ambulatory reflux monitoring due to logistical reasons, .
• Ability to provide written informed consent.

You may not qualify if:

• Prior oesophageal surgery other than POEM.
• Severe comorbidities limiting life expectancy (\<2 years).
• Pregnancy or lactation.
• Active gastrointestinal malignancy.
• Contraindication to PPI therapy.
• Inability to provide informed consent or comply with follow-up.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500032, India

Location

Related Publications (6)

• Singh AP, Singla N, Budhwani E, Januszewicz W, Memon SF, Inavolu P, Nabi Z, Jagtap N, Kalapala R, Lakhtakia S, Darisetty S, Reddy DN, Ramchandani M. Defining "true acid reflux" after peroral endoscopic myotomy for achalasia: a prospective cohort study. Gastrointest Endosc. 2024 Feb;99(2):166-173.e3. doi: 10.1016/j.gie.2023.08.008. Epub 2023 Aug 19.

  PMID: 37598862 BACKGROUND

• Nabi Z, Inavolu P, Duvvuru NR. Prediction, prevention and management of gastroesophageal reflux after per-oral endoscopic myotomy: An update. World J Gastroenterol. 2024 Mar 7;30(9):1096-1107. doi: 10.3748/wjg.v30.i9.1096.

  PMID: 38577183 BACKGROUND

• Samarasam I, Joel RK, Pulimood AB. Gastroesophageal reflux following per-oral endoscopic myotomy: Can we improve outcomes? World J Gastroenterol. 2024 Jun 14;30(22):2834-2838. doi: 10.3748/wjg.v30.i22.2834.

  PMID: 38947293 BACKGROUND

• Nabi Z, Basha J, Inavolu P, Goud R, Veligatla V, Tummuru SP, Cheripelli N, Arutla M, Ramchandani M, Darisetty S, Nageshwar Reddy D. Comprehensive analysis of nutritional parameters in patients with idiopathic achalasia: A prospective study in India. Indian J Gastroenterol. 2025 Feb;44(1):57-63. doi: 10.1007/s12664-024-01664-5. Epub 2024 Aug 19.

  PMID: 39158832 BACKGROUND

• Hazrah P. Reflux after peroral endoscopic myotomy: The dilemma and the options. World J Gastroenterol. 2025 Feb 14;31(6):100510. doi: 10.3748/wjg.v31.i6.100510.

  PMID: 39958445 BACKGROUND

• Bapaye A, Yewale R, Shah J, Bale R A, Ansari J, Borkar M, Bapaye H, Pujari R, Gadhikar H. Long-term (3-year) composite gastroesophageal reflux outcomes of peroral endoscopic myotomy with or without concomitant endoscopic fundoplication in matched cohorts of achalasia. Gastrointest Endosc. 2026 Feb;103(2):241-252. doi: 10.1016/j.gie.2025.04.029. Epub 2025 Apr 25.

  PMID: 40288696 BACKGROUND

Related Links

• Bapaye A, Yewale R, Shah J, Bale AR, Ansari J, Borkar M, et al. Long-term (3-year) composite gastroesophageal reflux outcomes of peroral endoscopic myotomy with or without concomitant endoscopic fundoplication in matched cohorts of achalasia. Gastrointes

MeSH Terms

Conditions

Esophageal Achalasia; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mohan Kumar Ramchandani, MD,DM

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and treating clinicians will not be blinded to treatment allocation. However, laboratory personnel, endoscopists, microbiome analysts, and outcome assessors will remain blinded to randomized group allocation where applicable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,DM, Director of interventional endoscopy

Model Details: Eligible post-POEM patients with objectively confirmed pathological reflux will be randomized in a 1:1 ratio to either structured biological optimization or standard post-POEM care. A separate prospective observational registry will enroll symptomatic post-POEM patients who are not eligible for randomization or unable to undergo reflux monitoring. Registry data will be analyzed separately from the randomized controlled trial.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 2, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)