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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03892252
• Other study ID #: V1.0
• Status: Completed
• Start date: March 10, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: September 2021
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: February 20, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Wei Xu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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