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

NCT07314151 | Recruiting

• 1 other identifier: CMUH113-REC2-014
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)

Keywords

inflammatory bowel disease, Crohn's disease, ulcerative colitis, gut brain axis, Traditional Chinese medicine (TCM) diagnosis, Tongue diagnosis, Metabolomics

Outcome Measures

Primary Outcomes (1)

• 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

  At enrollment (single visit; cross-sectional assessment)

Secondary Outcomes (8)

• Constitution in Chinese Medici n e Questionnaire, CCMQ

  At enrollment (single visit; cross-sectional assessment)

• Gastrointestinal Symptom Rating Scale , GSRS

  At enrollment (single visit; cross-sectional assessment)

• Hospital Anxiety and Depressio n Scale, HADS

  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)

Study Arms (2)

IBD Patient Cohort

Other: No intervention (observational study with diagnostic assessments only)

Healthy Control Cohort

Other: No intervention (observational study with diagnostic assessments only)

Interventions

No intervention (observational study with diagnostic assessments only) OTHER

This 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.

Healthy Control Cohort; IBD Patient Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Individuals with any diagnosed psychiatric disorder.
• Individuals with any major gastrointestinal disease, such as gastrointestinal malignancy.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, North, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 2, 2026
• Study Start: February 15, 2024
• Primary Completion: January 19, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

TW (1)