Biological Optimization Versus Standard Care in Post-POEM Achalasia Patients (BIO-POEM) (BIO-POEM 1)
Randomized Controlled Trial of Structured Biological Optimization Versus Standard Care With Embedded Prospective Registry in Post-POEM Achalasia Cardia Patients.
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Telangana
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Hyderabad, Telangana, Índia, 500032
- Asian Institute of Gastroenterology
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria for RCT
- 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.
Inclusion Criteria for Observational Registry
- 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.
Exclusion criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Structured Biological Optimization
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.
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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.
Outros nomes:
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Comparador Ativo: Standard Post-POEM Care
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.
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Score From Baseline to 12 Months
Prazo: Baseline and 12 months
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of Participants Successfully Discontinuing Proton Pump Inhibitor (PPI) or Potassium-Competitive Acid Blocker (PCAB) Therapy by 12 Months
Prazo: 6 months and 12 months
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Proportion of participants successfully discontinuing proton pump inhibitor (PPI) or potassium-competitive acid blocker (PCAB) therapy by 12 months after initiation of study intervention.
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6 months and 12 months
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Change in Leeds Dyspepsia Questionnaire Score From Baseline to 6 and 12 Months
Prazo: Baseline, 6 months, and 12 months
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Change in dyspepsia symptom severity assessed using the Leeds Dyspepsia Questionnaire. Higher scores indicate worse dyspepsia symptoms. |
Baseline, 6 months, and 12 months
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Change in Serum Vitamin D Levels From Baseline to 6 Months
Prazo: Baseline and 6 months
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Change in serum vitamin D levels measured in ng/mL.
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Baseline and 6 months
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Change in Serum Calcium Levels
Prazo: Baseline and 6 months
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Change in serum calcium levels measured in mg/dL.
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Baseline and 6 months
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Change in Serum Iron Levels
Prazo: Baseline and 6 months
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Change in serum iron levels measured in µg/dL.
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Baseline and 6 months
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Change in Serum Vitamin B12 Levels
Prazo: Baseline and 6 months
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Change in serum vitamin B12 levels measured in pg/mL.
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Baseline and 6 months
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Change in Serum Pre-albumin Levels
Prazo: Baseline and 6 months
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Change in serum pre-albumin levels measured in mg/dL.
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Baseline and 6 months
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Change in SF-36 Quality of Life Scores From Baseline to 6 and 12 Months
Prazo: Baseline, 6 months, and 12 months
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Change in health-related quality of life assessed using the 36-Item Short Form Survey (SF-36). SF-36 scores range from 0 to 100, with higher scores indicating better quality of life. |
Baseline, 6 months, and 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohan Kumar Ramchandani, MD,DM, Asian Institute of Gastroenterology
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Outros números de identificação do estudo
- BIO-POEM1
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