Pattern Identification in Patients with Functional Dyspepsia Using Brain-Body Bio-Signals: Protocol of a Clinical Trial for AI Algorithm Development.

Functional dyspepsia (FD) is a common functional gastrointestinal disorder characterized by chronic digestive symptoms without identifiable structural abnormalities. FD affects approximately 8-46% of the population, leading to significant socioeconomic burdens due to reduced quality of life and productivity. Traditional medicine utilizes differential diagnosis through comprehensive examinations, which include observing and questioning, abdominal examination, and pulse diagnosis for functional gastrointestinal disorders. However, challenges persist in the standardization and objectivity of diagnostic protocols. This study aims to develop an artificial intelligence-based algorithm to predict identified patterns in patients with functional dyspepsia by integrating brain-body bio-signals, including brain activity measured by functional near-infrared spectroscopy, pulse wave, skin conductance response, and electrocardiography. We will conduct an observational cross-sectional study comprising 100 patients diagnosed according to the Rome IV criteria, collecting bio-signal data alongside differential diagnoses performed by licensed Korean medicine doctors. The study protocol was reviewed and approved by the Institutional Review Board of Kyung Hee University Hospital at Gangdong on 25 January 2024 (IRB no. KHNMCOH 2023-12-003-003) and was registered in the Korean Clinical Trial Registry (KCT0009275). By creating AI algorithms based on bio-signals and integrating them into clinical practice, the objectivity and reliability of traditional diagnostics are expected to be enhanced. The integration of bio-signal analysis into the diagnostic process for patients with FD will improve clinical practices and support the broader acceptance of traditional-medicine diagnostic processes in healthcare.