Traditional Chinese Medicine diagnostics and tongue-coating metabolomics to characterize inflammatory bowel disease
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
This study will test whether TCM diagnostic tools and tongue-coating metabolomics can identify characteristic signs in adults with Crohn's disease or ulcerative colitis compared with people without IBD.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taichung, North) |
| Trial ID | NCT07314151 on ClinicalTrials.gov |
What this trial studies
An observational study at China Medical University Hospital will enroll two groups of about 30 adults each: patients with clinically diagnosed Crohn's disease or ulcerative colitis and control participants without significant gastrointestinal symptoms. Participants will undergo modern TCM diagnostic assessments (tongue imaging, pulse and auscultation instruments, and a TCM constitution questionnaire) alongside standard laboratory tests. Tongue coating samples will be analyzed by mass spectrometry to profile metabolites and compare patterns between IBD patients and controls. The project aims to link TCM phenotypes and metabolomic signatures with clinical status and explore differences between acute and remission phases.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) who can give informed consent and have a confirmed clinical diagnosis of Crohn's disease or ulcerative colitis, or healthy adults without significant GI symptoms for the control group.
Not a fit: People who are pregnant, recently had major surgery or cancer therapy, cannot complete study procedures, or have major gastrointestinal or psychiatric disorders (for controls) are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, this approach could provide noninvasive TCM-based markers from tongue coating and diagnostic measures to help distinguish IBD activity and inform prognosis.
How similar studies have performed: Small prior studies have reported links between tongue features or metabolomic profiles and gastrointestinal disease, but combining modern TCM diagnostics with tongue-coating metabolomics remains preliminary and not widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Taichung, North
- China Medical University Hospital — Taichung, North, Taiwan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.