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

NCT ID: NCT03892252

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-10

Study Completion Date

2020-02-20

Brief Summary

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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

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Conditions

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Colorectal Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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before surgery

no intervention(s)

No intervention

Intervention Type OTHER

No intervention

after surgery

no intervention(s)

No intervention

Intervention Type OTHER

No intervention

Normal colonoscopy

People who were diagnosed by colonoscopy without colorectal cancer.

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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;
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wei Xu

OTHER

Sponsor Role lead

Responsible Party

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Wei Xu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wei Xu, Professor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Harbin Medical University

Locations

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The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

Countries

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China

Other Identifiers

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V1.0

Identifier Type: -

Identifier Source: org_study_id

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