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

27. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

166

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Nahrungsergänzungsmittel: 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.
Andere Namen:
  • BIO-POEM Intervention
  • Post-POEM Biological Optimization Protocol
  • Structured Post-POEM Optimization Program BIO-POEM Care Pathway
Aktiver 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.
Nahrungsergänzungsmittel: 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.
Andere Namen:
  • BIO-POEM Intervention
  • Post-POEM Biological Optimization Protocol
  • Structured Post-POEM Optimization Program BIO-POEM Care Pathway

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Score From Baseline to 12 Months
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Asian Institute of Gastroenterology, India

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. Mai 2026

Primärer Abschluss (Geschätzt)

20. Dezember 2027

Studienabschluss (Geschätzt)

20. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

19. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Mai 2026

Zuerst gepostet (Tatsächlich)

2. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • BIO-POEM1

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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