Achalasia CardiaBIO-POEM 1NCT07620899
Biological Optimization Versus Standard Care in Post-POEM Achalasia Patients (BIO-POEM)
A study testing Structured Biological Optimization in people with Achalasia Cardia and GERD (Gastroesophageal Reflux Disease), run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Achalasia Cardia, GERD (Gastroesophageal Reflux Disease)
- What is being tested?
- Structured Biological Optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteIndia
- Study dates
- 20 May 2026to 20 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Structured Biological Optimization
- Keywords
- Achalasia cardia, per oral endoscopic myotomy, GERD, Helicobacter pylori, Micronutrient deficiency
- Medical subject headings
- Esophageal Achalasia, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Biological OptimizationDietary supplement
Also called BIO-POEM Intervention, Post-POEM Biological Optimization Protocol, Structured Post-POEM Optimization Program BIO-POEM Care Pathway
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.
| Study group | Role | What they receive |
|---|---|---|
| Structured Biological Optimization | Experimental | 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. Receives: Dietary Supplement: Structured Biological Optimization |
| Standard Post-POEM Care | Active comparator | 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. Receives: Dietary Supplement: Structured Biological Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Score From Baseline to 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.
Measured: Baseline and 12 months
Secondary outcomes (8)
Proportion of Participants Successfully Discontinuing Proton Pump Inhibitor (PPI) or Potassium-Competitive Acid Blocker (PCAB) Therapy by 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.
Measured: 6 months and 12 months
Change in Leeds Dyspepsia Questionnaire Score From Baseline to 6 and 12 Months
Change in dyspepsia symptom severity assessed using the Leeds Dyspepsia Questionnaire.
Higher scores indicate worse dyspepsia symptoms.
Measured: Baseline, 6 months, and 12 months
Change in Serum Vitamin D Levels From Baseline to 6 Months
Change in serum vitamin D levels measured in ng/mL.
Measured: Baseline and 6 months
Change in Serum Calcium Levels
Change in serum calcium levels measured in mg/dL.
Measured: Baseline and 6 months
Change in Serum Iron Levels
Change in serum iron levels measured in µg/dL.
Measured: Baseline and 6 months
Change in Serum Vitamin B12 Levels
Change in serum vitamin B12 levels measured in pg/mL.
Measured: Baseline and 6 months
Change in Serum Pre-albumin Levels
Change in serum pre-albumin levels measured in mg/dL.
Measured: Baseline and 6 months
Change in SF-36 Quality of Life Scores From Baseline to 6 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.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start20 May 2026
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Achalasia CardiaStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Mohan Kumar Ramchandani, MD,DM, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620899
- Sponsor's protocol ID
- BIO-POEM1
- Acronym
- BIO-POEM 1
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37598862Nabi 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.
PubMed 38577183Samarasam 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.
PubMed 38947293Nabi 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.
PubMed 39158832Hazrah 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.
PubMed 39958445Bapaye 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.
PubMed 40288696
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Structured Biological Optimization Versus Standard Care With Embedded Prospective Registry in Post-POEM Achalasia Cardia Patients.
- ClinicalTrials.gov ID
- NCT07620899
- Acronym / sponsor ID
- BIO-POEM 1 / BIO-POEM1
- Keywords
- Achalasia cardia, per oral endoscopic myotomy, GERD, Helicobacter pylori, Micronutrient deficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Structured Biological Optimization | Experimental | Dietary Supplement: Structured Biological OptimizationParticipants 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 OptimizationParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (6 listed)
- Prior oesophageal surgery other than POEM.
- Severe comorbidities limiting life expectancy (<2 years).
- Pregnancy or lactation.
- Active gastrointestinal malignancy.
- Contraindication to PPI therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Biological OptimizationAlso: BIO-POEM Intervention, Post-POEM Biological Optimization Protocol, Structured Post-POEM Optimization Program BIO-POEM Care PathwayA 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. | Dietary supplement | Standard Post-POEM Care, Structured Biological Optimization |
Primary outcome
Change in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Score From Baseline to 12 Months
Time frame: 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.
8 secondary outcomes
Proportion of Participants Successfully Discontinuing Proton Pump Inhibitor (PPI) or Potassium-Competitive Acid Blocker (PCAB) Therapy by 12 Months
Time frame: 6 months and 12 months
Change in Leeds Dyspepsia Questionnaire Score From Baseline to 6 and 12 Months
Time frame: Baseline, 6 months, and 12 months
Change in Serum Vitamin D Levels From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Serum Calcium Levels
Time frame: Baseline and 6 months
Change in Serum Iron Levels
Time frame: Baseline and 6 months
Change in Serum Vitamin B12 Levels
Time frame: Baseline and 6 months
Change in Serum Pre-albumin Levels
Time frame: Baseline and 6 months
Change in SF-36 Quality of Life Scores From Baseline to 6 and 12 Months
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 37598862Singh 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.
- Background: PubMed 38577183Nabi 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.
- Background: PubMed 38947293Samarasam 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.
- Background: PubMed 39158832Nabi 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.
- Background: PubMed 39958445Hazrah 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.
- Background: PubMed 40288696Bapaye 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.
- Bapaye A, Yewale R, Shah J, Bale AR, Ansari J, Borkar M, et al. Long-term (3-year) composite gastroesophageal reflux outcomes of peroral endoscopic myotomy with or without concomitant endoscopic fundoplication in matched cohorts of achalasia. GastrointesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohan Kumar Ramchandani, MD,DM principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Biological Optimization in people with Achalasia Cardia and GERD (Gastroesophageal Reflux Disease), run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Score From Baseline to 12 Months (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07620899, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.