Randomized Controlled Trial of Structured Biological Optimization Versus Standard Care With Embedded Prospective Registry in Post-POEM Achalasia Cardia Patients.
| Registry | NCT07620899, acronym BIO-POEM 1 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 166 (Estimated) |
| Sponsor | Asian Institute of Gastroenterology, India (Other) |
| Conditions | Achalasia Cardia, GERD (Gastroesophageal Reflux Disease) |
| Interventions | Structured Biological Optimization (Dietary supplement) |
| Dates | start 2026-05-20, primary completion 2027-12-20 (estimated), completion 2028-12-20 (estimated), first posted 2026-06-02, last updated 2026-06-02 |
| Locations | 1 site in India |
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All trials for Achalasia Cardia All trials for GERD (Gastroesophageal Reflux Disease) All trials of Structured Biological Optimization
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Structured Biological Optimization | Experimental | Dietary Supplement: 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. |
| Standard Post-POEM Care | Active comparator | Dietary Supplement: Structured Biological Optimization | 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. |
Sex: All, ages: 18 Years to 70 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Asian Institute of Gastroenterology | Hyderabad, Telangana | India |