Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

27 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

166

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Integratore alimentare: 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.
Altri nomi:
  • BIO-POEM Intervention
  • Post-POEM Biological Optimization Protocol
  • Structured Post-POEM Optimization Program BIO-POEM Care Pathway
Comparatore attivo: 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.
Integratore alimentare: 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.
Altri nomi:
  • BIO-POEM Intervention
  • Post-POEM Biological Optimization Protocol
  • Structured Post-POEM Optimization Program BIO-POEM Care Pathway

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Score From Baseline to 12 Months
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants Successfully Discontinuing Proton Pump Inhibitor (PPI) or Potassium-Competitive Acid Blocker (PCAB) Therapy by 12 Months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline and 6 months
Change in serum vitamin D levels measured in ng/mL.
Baseline and 6 months
Change in Serum Calcium Levels
Lasso di tempo: Baseline and 6 months
Change in serum calcium levels measured in mg/dL.
Baseline and 6 months
Change in Serum Iron Levels
Lasso di tempo: Baseline and 6 months
Change in serum iron levels measured in µg/dL.
Baseline and 6 months
Change in Serum Vitamin B12 Levels
Lasso di tempo: Baseline and 6 months
Change in serum vitamin B12 levels measured in pg/mL.
Baseline and 6 months
Change in Serum Pre-albumin Levels
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Asian Institute of Gastroenterology, India

Investigatori

  • Investigatore principale: Mohan Kumar Ramchandani, MD,DM, Asian Institute Of Gastroenterology

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 maggio 2026

Completamento primario (Stimato)

20 dicembre 2027

Completamento dello studio (Stimato)

20 dicembre 2028

Date di iscrizione allo studio

Primo inviato

19 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 maggio 2026

Primo Inserito (Effettivo)

2 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BIO-POEM1

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Structured Biological Optimization

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Singapore

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi