Colorectal adenoma
Conditions
Sponsors
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 65 years, with no gender restriction; (2) Underwent endoscopic resection within 90 days prior to enrollment, with histopathological confirmation of colorectal adenoma (tubular adenoma, villous adenoma, or mixed adenoma); (3) Single colorectal adenoma measuring =10 mm in size, or multiple adenomas (=2) with at least one measuring =5 mm; (4) No participation in any relevant drug clinical trials and no history of related medication use within 90 days before screening; (5) Good patient compliance, able to understand the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease), familial adenomatous polyposis (FAP), or hereditary nonpolyposis colorectal cancer (HNPCC); (2) Those with endoscopically or pathologically confirmed early carcinoma on the surface of a colorectal adenoma, with clear margins after resection; (3) Individuals with severe systemic diseases such as significant cardiac, hepatic, or renal dysfunction, which, in the opinion of the investigator, may confound the study results or compromise subject safety; (4) History of malignant tumor within 5 years prior to screening (subjects with cured basal cell carcinoma of the skin, cervical carcinoma in situ, or thyroid cancer may be included in this study); (5) Subjects with impaired consciousness or psychiatric disorders that prevent cooperation with the trial; (6) Pregnant women, suspected pregnant women, breastfeeding women, those planning pregnancy during the trial period, or female subjects with a positive urine pregnancy test; (7) Known hypersensitivity to any component of the investigational product or individuals with severe allergic constitution; (8) Participation in another drug clinical trial within 90 days prior to randomization; (9) Use of probiotics, antibiotics, or other medications affecting gut microbiota within 6 weeks prior to screening; (10) Any other condition deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adenoma recurrence rate;TCM Syndrome Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Carcinoembryonic Antigen (CEA), Carbohydrate Antigen 19-9 (CA19-9), Carbohydrate Antigen 72-4 (CA72-4), Carbohydrate Antigen 242 (CA242), Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT);Asia-Pacific Colorectal Cancer Screening Score;SF-36 Health Survey;SAS Anxiety Scale SDS Depression Scale;Polyp detection rate; | — |
Countries
China
Contacts
Public ContactMingyu Sun
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed