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

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Other: No intervention

• Registration Number: NCT03892252
• Lead Sponsor: Wei Xu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-10
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal colonoscopy	No intervention	People who were diagnosed by colonoscopy without colorectal cancer.
before surgery	No intervention	no intervention(s)
after surgery	No intervention	no intervention(s)

Primary Outcome Measures

Name	Time	Method
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 correlations	1 month
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 surgery	2 year

Trial Locations

Locations (1)

The First Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China