Traditional Chinese Medicine diagnostics and tongue-coating metabolomics to characterize inflammatory bowel disease
Official title: 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
Run by China Medical University Hospital · NCT07314151 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | China Medical University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taichung, North) |
| Status | Recruiting |
| Started | February 15, 2024 |
| Main results expected | January 19, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07314151 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
China Medical University Hospital
Taichung, North, Taiwan Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.