Study on the Use of Traditional Chinese Medicine Diagnostic Tools to Assist in Identifying the Clinical Characteristics of Inflammatory Bowel Disease and Research on Metabolic Plastids of Tongue Coating
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Tongue-coating metabolomic profiles in patients with inflammatory bowel disease compared with healthy controls
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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-K
- •Control group: Individuals without inflammatory bowel disease and without significant gastrointestinal symptoms.
排除标准
- •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.
- •Control group exclusions:
- •Individuals with any diagnosed psychiatric disorder.
- •Individuals with any major gastrointestinal disease, such as gastrointestinal malignancy.
结局指标
主要结局
Tongue-coating metabolomic profiles in patients with inflammatory bowel disease compared with healthy controls
时间窗: At enrollment (single visit; cross-sectional assessment)
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
次要结局
- Constitution in Chinese Medici n e Questionnaire, CCMQ(At enrollment (single visit; cross-sectional assessment))
- Hospital Anxiety and Depressio n Scale, HADS(At enrollment (single visit; cross-sectional assessment))
- Gastrointestinal Symptom Rating Scale , GSRS(At enrollment (single visit; cross-sectional assessment))
- Crohn's Disease Activity Index CDAI(At enrollment (single visit; cross-sectional assessment))
- Partial Mayo Scoring Index, pM ayo(At enrollment (single visit; cross-sectional assessment))
- Tongue diagnostic device(At enrollment (single visit; cross-sectional assessment))
- Listening diagnostic device(At enrollment (single visit; cross-sectional assessment))
- Pulse diagnostic device(At enrollment (single visit; cross-sectional assessment))