Biological Optimization Versus Standard Care in Post-POEM Achalasia Patients (BIO-POEM) (NCT07620899) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Biological Optimization Versus Standard Care in Post-POEM Achalasia Patients (BIO-POEM)
India166 participantsStarted 2026-05-20
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Score From Baseline to 12 Months