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Characteristics of Gut Microbiota in Patients With Colon Cancer of Different Traditional Chinese Medicine Syndromes

Correlation Analysis of TCM Syndromes, TCM Constitution Types, Intestinal Microbial Evolution and Tumor Biological Characteristics in Colorectal Cancer Patients Before and After Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03892252
Enrollment
192
Registered
2019-03-27
Start date
2019-03-10
Completion date
2020-02-20
Last updated
2021-09-28

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

Conditions

Colorectal Neoplasms

Keywords

gut microbiota, 16s rDNA sequebcing, TCM sydromes, TCM Constitution Types

Brief summary

Guided by the idea of combining disease differentiation with syndrome differentiation in traditional Chinese medicine, this study used the form of questionnaire to summarize the changes of TCM syndromes, TCM constitution types in colorectal cancer patients before and after surgery. The Next-generation sequencing technology was used to explore the changes and differences of intestinal microorganisms before and after surgery. The correlation between changes of TCM syndromes, TCM constitution types, intestinal microbial evolution and tumor biological characteristics in colorectal cancer patients before and after surgery was analyzed. To explore the rationality of TCM in the prevention and treatment of colorectal cancer recurrence and metastasis in order to guide the individualized treatment and dietary regulation of TCM.

Interventions

OTHERNo intervention

No intervention

Sponsors

Wei Xu
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

1. Preoperative abdominal CT, colonoscopy and pathological examination were diagnosed as colorectal malignant tumor patients; 2. Having surgical indications; 3. Patients who were not treated with antibiotics or microbiological agents one week before surgery; 4. Patients who had not received radiotherapy and chemotherapy before surgery; 5. Patients or their legal representatives informed and agreed to participate in this clinical trial and signed a written informed consent;

Exclusion criteria

1. Have other cancer history; 2. Patients who have received invasive treatment within the past three months; 3. Inflammatory bowel disease such as ulcerative colitis or crohn's disease; 4. Combined with intestinal obstruction or intestinal perforation for emergency surgery; 5. Psychiatric history, can not join and standardize the completion of clinical investigators; 6. Pregnant or nursing women; 7. Patients treated with antibiotics or microbiological agents one week before surgery; 8. People have incomplete data;

Design outcomes

Primary

MeasureTime frame
According to the 16s rDNA sequencing results, characterize the intestinal microbiota characteristics of colon cancer patients with different TCM syndrome types and TCM constitutions before and after surgery2 year
According to the 16s rDNA sequencing results, analyze the differences in intestinal flora of colon cancer patients with different TCM syndromes and TCM constitutions before and after surgery and their correlations1 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026