Association of gastric mucosal atrophy and upper gastrointestinal microbiota with esophageal squamous neoplasia: a prospective observational study

A prospective observational study to evaluate the association between gastric mucosal atrophy, upper gastrointestinal microbiota, and esophageal squamous neoplasia - GAMES Study (Gastric Atrophy and Microbiota in Esophageal Squamous neoplasia)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061932

Enrollment

140

Registered

2026-06-16

Start date

2026-06-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal squamous neoplasia (esophageal squamous cell carcinoma and high-grade intraepithelial neoplasia)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Adults aged 18 years or older -Individuals undergoing clinically indicated upper gastrointestinal endoscopy -Participants who meet one of the following criteria: (i) Patients with newly diagnosed superficial esophageal squamous neoplasia (esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia) (ii) Control patients without esophageal squamous neoplasia -Provision of written informed consent

Exclusion criteria

Exclusion criteria: -Patients with advanced esophageal cancer -History of esophageal squamous neoplasia -Patients with esophageal obstruction -Receipt of chemotherapy or radiotherapy within 6 months -Use of antibiotics within 8 weeks -Initiation or dose change of acid-suppressive medications or probiotics within 8 weeks -Participants judged to be ineligible by the investigator -Lack of or withdrawal of informed consent

Design outcomes

Primary

Measure	Time frame
Association of the degree of gastric mucosal atrophy and structural characteristics of the esophageal microbiota with the presence of esophageal squamous neoplasia	—

Secondary

Measure	Time frame
-Association between gastric mucosal atrophy and structural characteristics of the esophageal microbiota -Association between gastric mucosal atrophy and esophageal squamous neoplasia mediated by the esophageal microbiota -Differences in the composition of the esophageal microbiota in relation to gastric mucosal atrophy -Association between salivary microbiota and upper gastrointestinal microbiota (exploratory analysis) -Association of clinical background factors and genetic factors with gastric mucosal atrophy, esophageal microbiota, and esophageal squamous neoplasia	—

Measure

Time frame

-Association between gastric mucosal atrophy and structural characteristics of the esophageal microbiota -Association between gastric mucosal atrophy and esophageal squamous neoplasia mediated by the esophageal microbiota -Differences in the composition of the esophageal microbiota in relation to gastric mucosal atrophy -Association between salivary microbiota and upper gastrointestinal microbiota (exploratory analysis) -Association of clinical background factors and genetic factors with gastric mucosal atrophy, esophageal microbiota, and esophageal squamous neoplasia

—

Countries

Japan

Contacts

Public ContactKenta Watanabe

Akita University Graduate School of Medicine Department of Gastroenterology

nabeken@med.akita-u.ac.jp+81-18-884-6104

Outcome results