Achalasia CardiaNCT07451301
Serum Anti-enteric Neuronal Antibodies in Patients With Achalasia and Their Association With Clinical Profiles
An observational study of Achalasia Cardia, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Achalasia Cardia
- What is being tested?
- peroral endoscopic myotomy (POEM)
- Type of treatment
- Surgery or procedure
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 1 Nov 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- pregnant
- lactating
- with coexisting major gastrointestinal disorders
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
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
- Being tested
- peroral endoscopic myotomy (POEM)
- Keywords
- Anti-enteric neuronal antibody, Enteric nervous system, Disease Severity, Treatment Outcome, Achalasia Cardia
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peroral endoscopic myotomy (POEM)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: peroral endoscopic myotomy (POEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (4)
The Eckardt score
The Eckardt score was used to evaluate symptom severity in patients with AC. This composite score includes four components: dysphagia, retrosternal pain, regurgitation, and weight loss. Dysphagia, retrosternal pain, and regurgitation are each graded from 0 to 3 (0 = none; 1 = occasional; 2 = daily; 3 = at each meal). Weight loss is also scored from 0 to 3 (0 = none; 1 = < 5 kg; 2 = 5-10 kg; 3 = > 10 kg). The total score ranges from 0 to 12, with higher scores indicating greater symptom severity.
Measured: Baseline, 1-month follow-up after the procedure, 6-month follow-up after the procedure
Endoscopic evaluation
Endoscopic assessment was conducted using the CARS scoring system, a validated tool developed through video-based reliability testing and shown to correlate with disease severity. The CARS system allocates 0-2 points each for the domains of Contents, Anatomy, and Lower Esophageal Sphincter (LES) Resistance, and 1 point for each Stasis component.
Erosive esophagitis was graded according to the Los Angeles classification into four severity grades.
Measured: Baseline, 6-month follow-up
High-resolution manometry (HRM)
HRM was conducted per standard protocol, and key parameters were analyzed following the Chicago Classification version 4.0 criteria, including AC subtype, integrated relaxation pressure (IRP), basal LES pressure (BLESP), and distal contractile integral (DCI); and Radiologic assessment: A barium esophagogram was used to measure the maximum barium column width and assess esophageal tortuosity.
Measured: Baseline, 6-month follow-up
The degree of esophageal distortion on barium esophagogram
The degree of esophageal distortion on barium esophagogram was classified into four grades: None, mild, moderate, and severe. Mild distortion was defined as slight dilation or localized tortuosity with mild distal narrowing. Moderate distortion was characterized by a "C"-shaped or partial "S"-shaped configuration, whereas severe distortion included "L"-type or sigmoid-type esophagus. Senior gastroenterologists and radiologists with over 10 years of experience determined the grading.
Measured: Baseline, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Feb 2019
- Primary completion1 Mar 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achalasia CardiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Guo, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451301
- Sponsor's protocol ID
- I-25PJ0734
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Anti-enteric Neuronal Antibodies in Patients With Achalasia and Their Association With Clinical Profiles
- ClinicalTrials.gov ID
- NCT07451301
- Acronym / sponsor ID
- I-25PJ0734
- Conditions
- Achalasia Cardia
- Keywords
- Anti-enteric neuronal antibody, Enteric nervous system, Disease Severity, Treatment Outcome, Achalasia Cardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 5 Mar 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: peroral endoscopic myotomy (POEM)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- pregnant
- lactating
- with coexisting major gastrointestinal disorders
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 |
|---|---|---|
| peroral endoscopic myotomy (POEM)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. | Procedure or surgery | Achalasia patients |
Primary outcome
Proportion of Participants with Positive Serum Anti-Enteric Neuronal Antibodies (AENA)
Time frame: Baseline
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).
4 secondary outcomes
The Eckardt score
Time frame: Baseline, 1-month follow-up after the procedure, 6-month follow-up after the procedure
Endoscopic evaluation
Time frame: Baseline, 6-month follow-up
High-resolution manometry (HRM)
Time frame: Baseline, 6-month follow-up
The degree of esophageal distortion on barium esophagogram
Time frame: Baseline, 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia Cardia, run by Peking Union Medical College Hospital at 1 site in China.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 5 Mar 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of Participants with Positive Serum Anti-Enteric Neuronal Antibodies (AENA) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.