Serum Anti-enteric Neuronal Antibodies in Patients With Achalasia and Their Association With Clinical Profiles

NCT07451301 | Completed

• 1 other identifier: I-25PJ0734
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

Achalasia is a rare esophageal motility disorder characterized by impaired relaxation of the lower esophageal sphincter and progressive esophageal dilation. Increasing evidence suggests that autoimmune mechanisms may contribute to its development. Serum anti-enteric neuronal antibodies (AENA) have been reported more frequently in patients with achalasia than in healthy individuals. This study aims to evaluate the association between AENA levels and disease severity in patients with achalasia. Specifically, it aims to determine whether the intensity of AENA positivity is associated with endoscopic severity (measured by the CARS score), esophageal dilation, and integrated relaxation pressure. The study also aims to assess whether AENA status is associated with symptomatic outcomes following peroral endoscopic myotomy (POEM). The objective is to determine whether AENA may serve as a potential biomarker for identifying patients with a more severe disease phenotype and less favorable treatment response.

Conditions

Achalasia Cardia

Keywords

Anti-enteric neuronal antibody; Enteric nervous system; Disease Severity; Treatment Outcome; Achalasia Cardia

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants with Positive Serum Anti-Enteric Neuronal Antibodies (AENA)

  Serum AENA is assessed by indirect immunofluorescence using guinea pig intestinal submucosal whole-mount preparations. Patient sera are incubated with neuronal tissue, followed by fluorescein-conjugated secondary antibodies. Mouse anti-Hu antibody serves as a positive control and PBS as a negative control. Fluorescence intensity is graded by independent investigators as: 0 (negative), 1 (moderate positive), or 2 (strong positive). This measure reports the percentage of participants graded as 1 or 2 (AENA-positive rate).

  Baseline

Secondary Outcomes (4)

• The Eckardt score

  Baseline, 1-month follow-up after the procedure, 6-month follow-up after the procedure

• Endoscopic evaluation

  Baseline, 6-month follow-up

• High-resolution manometry (HRM)

  Baseline, 6-month follow-up

• The degree of esophageal distortion on barium esophagogram

  Baseline, 6-month follow-up

Study Arms (2)

healthy subjects

HS without gastrointestinal symptoms were recruited from the health examination center during the same period. All HS had normal physical and laboratory examination results. They were matched to patients with AC by age (± 2 years) and sex. Serum samples from HS were collected as part of routine health assessments, and both ANA and AENA testing were performed for all enrolled subjects.

Achalasia patients

Patients diagnosed with AC were consecutively enrolled. Inclusion criteria were: (1) Age between 18 and 75 years; (2) Fulfilment of the diagnostic criteria for AC according to the Chicago Classification version 4.0; and (3) Completion of symptomatic assessment, esophagogastroduodenoscopy, high-resolution manometry (HRM), and barium esophagram at PUMCH. Individuals who were pregnant, lactating, or those with coexisting major gastrointestinal disorders were excluded.

Procedure: peroral endoscopic myotomy (POEM)

Interventions

peroral endoscopic myotomy (POEM) PROCEDURE

A subset of eligible patients subsequently underwent POEM at our institution using the standardized technique described by Inoue et al. Postoperative follow-up assessments were conducted at 1, 3, and 6 months and included evaluation of Eckardt scores. At the 6-month follow-up, repeat esophagogastroduodenoscopy (with grading of erosive esophagitis according to the Los Angeles classification esophagitis), HRM, and barium esophagogram were performed.

Achalasia patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective cohort study included 97 patients with AC diagnosed according to the Chicago Classification version 4.0 and 98 age- and sex-matched healthy subjects (HS).

You may qualify if:

• Age between 18 and 75 years;
• Fulfilment of the diagnostic criteria for AC according to the Chicago Classification version 4.0
• Completion of symptomatic assessment, esophagogastroduodenoscopy, high-resolution manometry (HRM), and barium esophagram.

You may not qualify if:

• pregnant
• lactating
• with coexisting major gastrointestinal disorders

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 5, 2026
• Study Start: February 1, 2019
• Primary Completion: March 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CN (1)