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Construction and Application of an Artificial Intelligence-Based Helicobacter pylori Infection Screening Model Using Tongue Pattern Recognition

Construction and Application of an Artificial Intelligence-Based Helicobacter pylori Infection Screening Model Using Tongue Pattern Recognition: A Multicenter, Cross-Sectional Diagnostic Model Development and Validation Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116166
Enrollment
Unknown
Registered
2026-01-06
Start date
2026-01-06
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Helicobacter pylori infection

Interventions

Gold Standard:¹³C Urea Breath Test
Index test:Artificial Intelligence-Based Tongue Pattern Recognition Model

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-70 years, no gender restrictions; 2.Patients undergoing ¹³C urea breath test (manufacturer restricted to Hidewei or 75 mg Huagen; breath value >6 deemed positive, <2 deemed negative; patients with breath values within the borderline range excluded from enrollment); 3.Voluntary participation and signed informed consent;

Exclusion criteria

Exclusion criteria: 1.Patients who have undergone H. pylori drug therapy or taken other Chinese herbal medicines within the past 4 weeks; 2.Patients with difficulty opening their mouths or unable to fully expose their tongues; 3.Patients with tongue piercings or who have undergone tongue modification procedures (e.g., tongue clipping); 4.Patients who underwent tongue coating cleaning within the past week; 5.Patients who consumed colored foods (staining the tongue coating) on the day of examination; 6.Patients with dental or gum diseases and other oral conditions; 7.Patients with recurrence of H. pylori infection after successful eradication within the past year; 8.Other factors deemed by the investigator to make the patient unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
Area under the ROC curve;Positive Predictive Value;Sensitivity;Specificity;Negative predictive value;Accuracy rate;

Countries

China

Contacts

Public ContactHu Yi

The First Affiliated Hospital of Nanchang University

360041934@qq.com+86 180 7914 0226

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026