Achalasia Cardia, GERD (Gastroesophageal Reflux Disease)
Conditions
Keywords
Achalasia cardia, per oral endoscopic myotomy, GERD, Helicobacter pylori, Micronutrient deficiency
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTStructured 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.
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Score From Baseline to 12 Months | Baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Successfully Discontinuing Proton Pump Inhibitor (PPI) or Potassium-Competitive Acid Blocker (PCAB) Therapy by 12 Months | 6 months and 12 months | Proportion of participants successfully discontinuing proton pump inhibitor (PPI) or potassium-competitive acid blocker (PCAB) therapy by 12 months after initiation of study intervention. |
| Change in Leeds Dyspepsia Questionnaire Score From Baseline to 6 and 12 Months | Baseline, 6 months, and 12 months | Change in dyspepsia symptom severity assessed using the Leeds Dyspepsia Questionnaire. Higher scores indicate worse dyspepsia symptoms. |
| Change in Serum Vitamin D Levels From Baseline to 6 Months | Baseline and 6 months | Change in serum vitamin D levels measured in ng/mL. |
| Change in Serum Calcium Levels | Baseline and 6 months | Change in serum calcium levels measured in mg/dL. |
| Change in Serum Iron Levels | Baseline and 6 months | Change in serum iron levels measured in µg/dL. |
| Change in Serum Vitamin B12 Levels | Baseline and 6 months | Change in serum vitamin B12 levels measured in pg/mL. |
| Change in Serum Pre-albumin Levels | Baseline and 6 months | Change in serum pre-albumin levels measured in mg/dL. |
| Change in SF-36 Quality of Life Scores From Baseline to 6 and 12 Months | Baseline, 6 months, and 12 months | 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. |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORMohan Kumar Ramchandani, MD,DM
Asian Institute of Gastroenterology
Outcome results
None listed