This study will be conducted at the outpatient clinic of China Medical University hospital. It is expected to enroll two groups of 30 subjects, including the experimental group must meet the clinical diagnosis of IBD, and the control group without IBD and have no obvious gastrointestinal symptoms . This proje ct uses modern TCM diagnostic tools, such as tongue diagnosis instrument, auscul tation instrument, TCM constitution questionnaire, and pulse diagnosis instrument to establish the comparison of physiological and biochemical indicators such as TCM phenotype and laboratory tests data in patients with IBD. Besides, another purpose of this project is to analyze the tongue coating metabolites of patients with IBD by mass spectrometry, and to establish a research model of tongue coating an d metabolomics for patien ts with IBD and the prognosis analysis of acute and remission phases.
Adult patients aged 18 years or older who are able to provide informed consent and comply with the study procedures.
Experimental group: Patients with a primary diagnosis of Crohn's disease or ulcerative colitis, defined by ICD-10-CM codes K50-K51.
Control group: Individuals without inflammatory bowel disease and without significant gastrointestinal symptoms.
Individuals who are unable to provide informed consent or unable to comply with study procedures or questionnaires.
Individuals who have undergone major surgery or received chemotherapy or radiotherapy within the past month.
Pregnant women.
Individuals deemed unsuitable for participation in this study by the attending physician.
The study will be conducted in the outpatient clinics of China Medical University Hospital and is designed to enroll two groups of participants, with 100 individuals aged 18 years or older in each group. The experimental group will include patients who meet the clinical diagnostic criteria for inflammatory bowel disease (IBD), while the control group will consist of individuals without IBD and without significant gastrointestinal symptoms. All participants will receive a detailed explanation of the study from research personnel. Those who agree to participate and pass the initial screening will be required to sign an informed consent form for human clinical research and subsequently undergo the relevant assessments and procedures.
Case-control
Cross-sectional
No intervention (observational study with diagnostic assessments only)
Other interventionThis observational study involves no therapeutic or behavioral intervention. Participants undergo non-invasive assessments including Traditional Chinese Medicine four-diagnostic measurements (inspection, listening/smelling, inquiry, and pulse assessment), completion of standardized questionnaires, and collection of tongue-coating samples for metabolomic analysis.
Tongue-coating metabolomic profiles in patients with inflammatory bowel disease compared with healthy controls
After tongue-coating collection, the samples (approximately 20-50 mg) are weighed and stored at -80 °C until all samples have been collected. Metabolite extraction is then performed, followed by analysis of metabolite signals using liquid chromatography-mass spectrometry. The primary analytical platform consists of an ACQUITY UPLC I-Class System (Waters) coupled with a Vion IMS Q-ToF mass spectrometer (Waters). The acquired chromatographic and mass spectrometric data are further processed using the omics analysis software Progenesis QI to identify intergroup differences. Metabolite signal differences between the acute and remission phases are evaluated using principal component analysis (PCA) and partial least squares discriminant analysis (PLS-DA). Subsequently, differential metabolite signals are matched against reference databases for metabolite identification. Upon completion of metabolite identification and data acquisition, disease phase-specific metabolomic signature patterns
Constitution in Chinese Medici n e Questionnaire, CCMQ
During participant enrollment, questionnaires are administered by research personnel. Participants are instructed to complete the questionnaires independently based on their subjective perceptions, with efforts made to minimize external interference that may influence their responses. Questionnaire results are scored and categorized according to the established scoring criteria.
Gastrointestinal Symptom Rating Scale , GSRS
The Gastrointestinal Symptom Rating Scale (GSRS) assesses 15 common gastrointestinal symptoms grouped into five symptom domains: abdominal pain, diarrhea, gastroesophageal reflux, indigestion, and constipation. Each item is rated on a 7-point Likert scale ranging from "no discomfort" to "very severe discomfort," with participants self-assessing the severity of their gastrointestinal symptoms over the preceding week. Higher scores indicate greater symptom severity. The GSRS provides a brief yet comprehensive assessment of common gastrointestinal symptoms and demonstrates good internal consistency and psychometric validity. The reported Cronbach's alpha values range from 0.74 to 0.85, and the test-retest reliability ranges from 0.55 to 0.70.
Hospital Anxiety and Depressio n Scale, HADS
The Hospital Anxiety and Depression Scale (HADS) consists of 14 items, with 7 items assessing anxiety (HADS-A) and 7 items assessing depression (HADS-D), each scored separately. Items are rated on a 4-point scale ranging from 0 to 3, with higher scores indicating greater severity of anxiety or depression. According to the original authors' recommendations, scores of 7 or below indicate no anxiety or depression, scores of 8-10 suggest possible anxiety or depression, and scores of 11 or higher indicate a high likelihood of clinically significant anxiety or depression.
Crohn's Disease Activity Index CDAI
The assessment consists of eight clinical variables, including subjective symptoms over the preceding week (such as abdominal pain severity and overall well-being), objective measures (such as the use of antidiarrheal medications and percentage change in body weight), and laboratory parameters. After individual component scores are recorded, a weighted calculation is applied to generate the total score. Higher scores indicate greater disease activity, with a CDAI score of less than 150 indicating disease remission and a score greater than 450 indicating extremely severe disease activity.
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