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Chinese medicine diagnostic characteristics of patients with Crohn's disease with stenosis based on colony-metabolism analysis

Chinese medicine diagnostic characteristics of patients with Crohn's disease with stenosis based on colony-metabolism analysis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025000322
Enrollment
Unknown
Registered
2025-02-18
Start date
2024-05-21
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

narrow group:observational study
Patients undergoing intestinal surgery for non-Crohn's disease:Receive intestinal tissue samples and feces
No-narrow group:observational study
Stenosis patients group:Receive intestinal tissue samples and feces

Sponsors

Jiangsu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for patients with CD with stenosis (1) Patients who meet the western medical diagnostic criteria for Crohn's disease. (2) Patients who meet the diagnostic criteria for CD stenosis by imaging endoscopy or ultrasound. (3) Complete medical records and fulfillment of statistical needs. The basic clinical data included: complete history and description of symptoms laboratory tests (routine blood C-reactive protein fecal calprotectin blood sedimentation liver and kidney function). (4) Informed consent and voluntary subjects. The process of obtaining informed consent was in accordance with GCP. 2. CD with stenosis surgery patients enrollment criteria (1) Patients meeting the western medical diagnostic criteria for Crohn's disease. (2) Patients who met the diagnostic criteria for CD stenosis by imaging endoscopy or ultrasound. (3) Complete medical records and fulfillment of statistical needs. The basic clinical data include: complete history and description of symptoms laboratory tests (blood routine C-reactive protein fecal calprotectin blood sedimentation liver and kidney function). (4) Patients with an indication for CD surgery and undergoing stenotomy. (5) Informed consent and voluntary subjects. The process of obtaining informed consent was in accordance with GCP regulations. 3. Inclusion criteria for the control group (1) Healthy subjects without relevant intestinal diseases. (2) Informed consent and voluntary testing. The process of obtaining informed consent is in accordance with GCP regulations.

Exclusion criteria

Exclusion criteria: 1. Exclude infectious colitis such as intestinal tuberculosis bacillary dysentery amoebic dysentery and diseases such as ischemic colitis ulcerative colitis intestinal leukosis and ischemic colitis; 2. exclude those with immune-related diseases such as rheumatoid arthritis and systemic lupus erythematosus; 3. exclude systemic metabolic diseases such as diabetes mellitus metabolic syndrome etc. 4. patients who may interfere with the results of the study or have other additional risks; 5. those who are unable to give full informed consent due to intellectual or behavioral disabilities. 6. allergy such as those with a history of allergy to two or more drugs or foods.

Design outcomes

Primary

MeasureTime frame
Measuring differences in different flora in feces;Measurement of untargeted metabolites in intestinal tissues;Number of anaerobes and differential anaerobes in the measured flora;

Secondary

MeasureTime frame
Defining differential metabolites in intestinal tissues;

Countries

China

Contacts

Public ContactHong Shen

Affiliated Hospital of Nanjing University of Chinese Medicine

shenhong999@njucm.edu.cn13851872859

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026