Clinical Study of PEG Bowel Preparation in Appendectomy Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHuaping Xie
About this trial
Colonoscopy is a necessary item of physical examination for colorectal cancer. For high-risk groups, annual physical examination is the most effective way of early prevention; At present, a large amount of polyethylene glycol (PEG2000 - 4000) is often used as laxative and lubricant in colonoscopy. However, the widespread use of PEG may cause long-term and irreversible damage to intestinal microorganisms and bring great hidden dangers to health. The appendix has long been regarded as a redundant organ in evolution. The incidence of appendicitis ranks first in surgical acute abdomen. Traditionally, once acute appendicitis is diagnosed, it is usually treated with appendectomy. However, recent studies have revealed that appendectomy may be associated with psychiatric diseases, colorectal cancer, cardiovascular diseases and other diseases. The appendix is not only an important organ of the immune system, but also undertakes the function of storing and protecting intestinal microbes.. . This change may affect the function of the central nervous system through the microbe gut brain axis, and then pose a potential threat to the health and behavior of the host, such as increasing the risk of diseases such as Parkinson's disease. Based on this, this clinical trial aims to investigate (1) the changes of intestinal flora in the appendectomy population before and after colonoscopy in the process of polyethylene glycol intestinal preparation; (2) the differences between the changes of intestinal flora before and after colonoscopy in the appendicectomy population and the normal population in the process of flora recovery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18-75 years.
Scheduled to undergo colonoscopy.
Generally healthy without major organ diseases.
For appendectomy group: history of appendectomy or right hemicolectomy (including appendectomy).
Disqualifiers
Allergy or intolerance to PEG laxatives.
Pregnant or lactating women.
Mental disorders.
Use of antibiotics within 6 months prior to study enrollment.
Trial population
The research subjects were adult patients from the Department of Gastroenterology of Tongji Hospital in Wuhan, China, who were scheduled to undergo colonoscopy. Participants were recruited continuously from the outpatient department and voluntarily joined after signing a written informed consent form. The participants were divided into two cohorts based on their history of appendectomy: individuals with a history of appendectomy (appendectomy group) and those without an appendectomy (normal group). All participants received routine bowel preparation using polyethylene glycol and provided fecal samples regularly within 6 months. No experimental interventions were conducted.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bowel Preparation with Polyethylene Glycol (PEG) Laxatives
DrugAll subjects will undergo bowel preparation by taking Polyethylene Glycol (PEG) electrolyte powder according to the clinical routine requirements for colonoscopy. The specific dosage and administration will follow the hospital's standardized protocol. Researchers will record the usage of PEG.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Appendectomy Group1 intervention
Group B: Non-Appendectomy Group1 intervention
Trial outcomes
Primary outcomes
1
Change in Relative Abundance of Specific Gut Microbes
To analyse the changes in relative abundance of specific gut microbes before and after colonoscopy in patients with appendectomy. According to the species abundance table of each species, relative abundance profile display and cluster thermogram display will be carried out. Linear discriminant analysis Effect Size (LEfSe) will be performed using Kruskal-Wallis test and Wilcoxon rank-sum test to identify features with statistically significant differences between groups .
Time frame
Baseline (pre-colonoscopy), 1 month, 3 months, 6 months post-colonoscopy2
2.Difference in Gut Microbiota Recovery Trajectory Between Appendectomy and Non-Appendectomy Groups
To compare the recovery trajectory of the gut microbiota after colonoscopy between patients with appendectomy and control subjects without appendectomy. By comparing the degree of change from baseline in alpha diversity, beta diversity, and relative abundance of specific microbes at 1 month, 3 months, and 6 months post-colonoscopy between the two groups, the role of the appendix in microbiota recovery will be assessed.
Time frame
Baseline (pre-colonoscopy), 1 month, 3 months, 6 months post-colonoscopy3
3.Change in Metabolic Function of Gut Microbiota
To analyse the changes in metabolic function of the gut microbiota before and after colonoscopy in patients with appendectomy. Based on gene annotation results from metagenomic sequencing, the ko gene family will be mapped to the KEGG database to obtain metabolic function annotation information. Differences in the relative abundance of metabolic pathways (e.g., carbohydrate metabolism, short-chain fatty acid synthesis, amino acid metabolism) in fecal microbiota will be compared across time points. Inter-group differences will be analyzed using STAMP software or R packages.
Time frame
Baseline (pre-colonoscopy), 1 month, 3 months, 6 months post-colonoscopySponsors and contacts
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Huaping Xie
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov