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Biological Optimization Versus Standard Care in Post-POEM Achalasia Patients (BIO-POEM) (BIO-POEM 1)

27. maj 2026 opdateret af: Mohan Ramchandani, Asian Institute of Gastroenterology, India

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.

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

166

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Indien
    • Telangana
      • Hyderabad, Telangana, Indien, 500032
        • Asian Institute Of Gastroenterology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Kosttilskud: Structured 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.
Andre navne:
  • BIO-POEM Intervention
  • Post-POEM Biological Optimization Protocol
  • Structured Post-POEM Optimization Program BIO-POEM Care Pathway
Aktiv komparator: Standard Post-POEM Care
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.
Kosttilskud: Structured 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.
Andre navne:
  • BIO-POEM Intervention
  • Post-POEM Biological Optimization Protocol
  • Structured Post-POEM Optimization Program BIO-POEM Care Pathway

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Score From Baseline to 12 Months
Tidsramme: 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.
Baseline and 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants Successfully Discontinuing Proton Pump Inhibitor (PPI) or Potassium-Competitive Acid Blocker (PCAB) Therapy by 12 Months
Tidsramme: 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.
6 months and 12 months
Change in Leeds Dyspepsia Questionnaire Score From Baseline to 6 and 12 Months
Tidsramme: Baseline, 6 months, and 12 months

Change in dyspepsia symptom severity assessed using the Leeds Dyspepsia Questionnaire.

Higher scores indicate worse dyspepsia symptoms.
Baseline, 6 months, and 12 months
Change in Serum Vitamin D Levels From Baseline to 6 Months
Tidsramme: Baseline and 6 months
Change in serum vitamin D levels measured in ng/mL.
Baseline and 6 months
Change in Serum Calcium Levels
Tidsramme: Baseline and 6 months
Change in serum calcium levels measured in mg/dL.
Baseline and 6 months
Change in Serum Iron Levels
Tidsramme: Baseline and 6 months
Change in serum iron levels measured in µg/dL.
Baseline and 6 months
Change in Serum Vitamin B12 Levels
Tidsramme: Baseline and 6 months
Change in serum vitamin B12 levels measured in pg/mL.
Baseline and 6 months
Change in Serum Pre-albumin Levels
Tidsramme: Baseline and 6 months
Change in serum pre-albumin levels measured in mg/dL.
Baseline and 6 months
Change in SF-36 Quality of Life Scores From Baseline to 6 and 12 Months
Tidsramme: 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.
Baseline, 6 months, and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Asian Institute of Gastroenterology, India

Efterforskere

  • Ledende efterforsker: Mohan Kumar Ramchandani, MD,DM, Asian Institute Of Gastroenterology

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. maj 2026

Primær færdiggørelse (Anslået)

20. december 2027

Studieafslutning (Anslået)

20. december 2028

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BIO-POEM1

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Achalasia Cardia

Kliniske forsøg med Structured Biological Optimization

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