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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05066048
Other study ID # XJTU1AF-CRF-2020-004
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 30, 2021
Est. completion date January 31, 2024

Study information

Verified date March 2022
Source First Affiliated Hospital Xi'an Jiaotong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

As a good niche for bacterial growth, appendix plays a very important role in maintaining and protecting intestinal symbiotic flora. Appendectomy will lead to intestinal microecological disorders. Therefore, we put forward the hypothesis that "appendectomy leads to intestinal microecological disorders and then increases the risk of colorectal cancer". In this study, the feces of normal controls, appendectomy and patients with colorectal cancer were collected, and the specific changes of intestinal flora after appendectomy were explored in detail from the level of family, genus and species by macrogenomic sequencing. Then through functional gene analysis, metabolic pathway analysis and other methods to explore the molecular mechanism of colorectal cancer risk changes and the changes of microflora involved, and verified by mouse fecal bacteria transplantation animal experiment.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date January 31, 2024
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria: - Patients undergoing appendectomy due to appendicitis; - 6-36 months after appendectomy; - Patients with no obvious abnormality observed by colonoscopy; - Age between 20 and 85. Exclusion Criteria: - A. Any history of malignancy or disease - Any inflammatory bowel disease (IBD) prior to study inclusion; - Antibiotics and hormone drugs taken within the last three months; - Patients with severe systemic diseases (severe diabetes, hypertension or autoimmune diseases, etc.); - Severe clinical symptoms of digestive tract (severe diarrhea, constipation, purulent disease, etc.) within half a year.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The First Affiliated Hospital of Xi'an Jiao Tong University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Species composition of fecal microbial The types of microorganisms of fecal microbial 1 year
Secondary weight in kilograms weight of enrolled patients baseline, pre-procedure
Secondary height in meters height of enrolled patients baseline, pre-procedure
Secondary age in year age of enrolled patients baseline, pre-procedure
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