Randomized Controlled Trial of Structured Biological Optimization Versus Standard Care With Embedded Prospective Registry in Post-POEM Achalasia Cardia Patients.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 166
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Mohan Ramchandani
MD,DM, Director of interventional endoscopy
Asian Institute of Gastroenterology, India